Cell-DYN
CELL-DYN Immuno T-Cell (CD3/4/8) Reagents
3manufacturers in China registered for this device type
19catalogue numbers in this listing
24510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| VTech Communications Ltd | Dongguan | Guangdong | Contract manufacturer | 5 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Onechipdx Biotech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Specification developer | 2 |
Record
| Listed by | Abbott Laboratories, United States |
|---|---|
| FDA product code | GKZ |
| Device type | Counter, Differential Cell |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5220 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K991605 |
| Record published | 2016-09-09 |
| Record revised | 2024-05-16 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature -10 to 50 °C |
| Distribution end date | 2021-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 09H5901 | In distribution | |
| 09H39-01 | In distribution | |
| 08H00-01 | In distribution | |
| 04R1301 | In distribution | |
| 08H00-03 | In distribution | |
| 08H67-01 | In distribution | |
| 08H67-03 | In distribution | |
| 07H22-01 | In distribution | |
| 03H05-01 | In distribution | |
| 04H59-03 | Withdrawn | |
| 02H30-03 | Withdrawn | |
| 04H59-01 | Withdrawn | |
| 07H77-03 | Withdrawn | |
| 04H60-01 | Withdrawn | |
| 02H30-01 | Withdrawn | |
| 07H77-01 | Withdrawn | |
| 04H60-03 | Withdrawn | |
| 02H31-03 | Withdrawn | |
| 02H31-01 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QBC Diagnostics | Drucker Diagnostics, LLC | 41 |
| Research and Diagnostic Systems | Research AND Diagnostic Systems, Inc. | 17 |
| Simultest | Becton, Dickinson AND Company | 10 |
| BD FACSCanto™ | Becton, Dickinson AND Company | 10 |
| FACSCanto | Becton, Dickinson AND Company | 7 |
| BD Multitest | Becton, Dickinson AND Company | 6 |
| Coulter AcT | Beckman Coulter, Inc. | 6 |
| BD™ Multi-Check | Becton, Dickinson AND Company | 6 |
| BD Tritest | Becton, Dickinson AND Company | 6 |
| Coulter LH | Beckman Coulter, Inc. | 5 |
| HemoScreen | Pixcell Medical Inc. | 5 |
| Calibrite | Becton, Dickinson AND Company | 4 |
Showing 12 of 245. All products under Counter, Differential Cell
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243283 | 2025-02-20 |
| K220031 | 2023-08-04 |
| K190294 | 2019-03-15 |
| K110381 | 2011-12-22 |
| K081495 | 2009-02-04 |
| K061667 | 2006-07-10 |
| K051215 | 2005-07-21 |
| K030513 | 2003-05-12 |
| K012934 | 2001-09-28 |
| K010953 | 2001-06-06 |
| K992444 | 1999-09-24 |
| K991605 | 1999-07-09 |
| K991142 | 1999-06-23 |
| K981342 | 1998-06-29 |
| K980614 | 1998-04-24 |
| K972354 | 1997-09-16 |
| K971152 | 1997-08-12 |
| K955715 | 1996-10-08 |
| K955673 | 1996-05-20 |
| K951496 | 1995-10-19 |
| K930309 | 1993-07-14 |
| K803219 | 1981-01-21 |
| K800533 | 1980-04-04 |
| K770244 | 1977-08-04 |
Recalls Naming This Product
17 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Abbott Laboratories | UDI-DI | 2025-03-18 | Class II | Software change control | When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of t | 2947 | |
| Abbott Laboratories | UDI-DI | 2025-03-18 | Class II | Software change control | When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of t | 146 | |
| Abbott Laboratories | UDI-DI | 2025-03-18 | Class II | Software change control | When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of t | 19 | |
| Abbott Laboratories | UDI-DI | 2025-03-18 | Class II | Software change control | When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of t | 1 | |
| Abbott Laboratories | UDI-DI | 2025-03-18 | Class II | Software change control | When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of t | 45 | |
| Abbott Laboratories | UDI-DI | 2023-10-19 | Class II | Under Investigation by firm | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). | 670 devices (329 US and 341 OUS) | |
| Abbott Laboratories | 510(k) number | 2011-03-15 | Not classified | Pending | The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results. | 174 total instruments, all varieties. | 2011-11-22 |
| Abbott Laboratories | 510(k) number | 2011-03-15 | Not classified | Pending | The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results. | 174 total, all varieties | 2011-11-22 |
| Abbott Laboratories | 510(k) number | 2011-03-15 | Not classified | Pending | The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results. | 174 instruments total, all varieties | 2011-11-22 |
| Abbott Laboratories | 510(k) number | 2011-03-15 | Not classified | Pending | The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results. | 174 total units, all varieties | 2011-11-22 |
| Abbott Laboratories | 510(k) number | 2010-04-16 | Not classified | Nonconforming Material/Component | Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks. | 69 units total | 2010-12-06 |
| Abbott Laboratories | 510(k) number | 2009-11-30 | Not classified | Other | The use of the device assemblies has been extended to a 6 month useful life. | 874 | 2011-03-18 |
| Abbott Laboratories | 510(k) number | 2009-03-27 | Not classified | Component design/selection | FIRE HAZARD– Some power supply modules may have incorrect fuses installed, which may result in fires and smoking. | 2961 units | 2011-12-21 |
| Abbott Laboratories | 510(k) number | 2009-03-27 | Not classified | Component design/selection | FIRE HAZARD– Some power supply modules may have incorrect fuses installed, which may result in fires and smoking. | 2961 units | 2011-12-21 |
| Abbott Laboratories | 510(k) number | 2007-05-11 | Not classified | Other | The product failed electrostatic discharge testing, which could result in product failure. | 3,429 units, all models | 2008-06-19 |
| Abbott Laboratories | 510(k) number | 2007-05-11 | Not classified | Other | The product failed electrostatic discharge testing, which could result in product failure. | 3,429 units, all models | 2008-06-19 |
| Abbott Laboratories | 510(k) number | 2006-10-27 | Not classified | Software design | Incorrect Results: Hemoglobin results in donor samples assayed on the CELL-DYN 1800 System vary more than expected across the range of claimed operating temperatures of 18 degrees Celcius to 30 degrees Celcius. | 4,224 Systems | 2011-01-06 |
Recalls
6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-09-18 | Class II | Software design | Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results. | 833 | |
| 2024-06-14 | Class II | Software design | 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell H | 816 | |
| 2019-05-09 | Class II | Nonconforming Material/Component | The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results. | 22 analyzers with tubing | 2020-10-07 |
| 2019-02-20 | Class II | Under Investigation by firm | There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT. | 6,353 units | 2021-08-13 |
| 2017-02-13 | Class II | Nonconforming Material/Component | The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage | 116 | 2018-03-06 |
| 2016-03-24 | Class II | Under Investigation by firm | Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality Control Out of Range Low for parameters RBC and PLT. | 10,364 plus 9410 additional units for recall expansion. | 2017-01-04 |
| 2011-03-15 | Not classified | Pending | The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results. | 174 total units, all varieties | 2011-11-22 |
| 2011-03-15 | Not classified | Pending | The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results. | 174 total units, all varieties | 2011-11-22 |
| 2011-03-15 | Not classified | Pending | The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results. | 174 total units, all varieties | 2011-11-22 |
| 2010-10-15 | Not classified | Other | There is the potential for the instrument to not power up due to the flash memory issue. This will result in an error message displayed is “No Memory Available” and has the potential for delay in generating patient results. | 2011-06-07 | |
| 2010-09-30 | Not classified | Error in labeling | The product bar code label, when scanned, indicates that the volume is 10 mL rather than the correct volume of 10,000 mL. Analytical results are not impacted, although, there is a potential for delay in generating results. | 322 units | 2011-04-07 |
| 2010-07-23 | Not classified | Process control | The Vent Needle, which is built into the Vent Head Assembly on the CELL-DYN Sapphire Instrument and which is used directly on the CELL-DYN 4000 Instrument, may be defective, which may result in an undetected short sample, generating incorre | 2011-09-01 | |
| 2010-04-16 | Not classified | Nonconforming Material/Component | Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks. | 69 units total. | 2010-12-06 |
| 2010-04-16 | Not classified | Nonconforming Material/Component | Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks. | 69 units total | 2010-12-06 |
| 2010-04-16 | Not classified | Nonconforming Material/Component | Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks. | 69 units total | 2010-12-06 |
| 2010-04-05 | Not classified | Other | Under certain conditions in closed mode of operations, the Aspiration Probe Detector PCB assembly may fail to operate properly and provide inaccurate results. | 926 units | 2011-05-17 |
| 2010-03-23 | Not classified | Software design (manufacturing process) | Abbott has determined that gain settings for the non-standard specimen types may not match the gain settings for the standard specimen type. There is the potential for impact to product performance. | 891 units | 2011-03-18 |
| 2009-12-29 | Not classified | Other | A component used in assembly is out of specification, resulting in failure to retract, eject specimens, exposure below the safety zone, piercing of specimen tubes, or error message to display. | 157 assemblies | 2011-03-11 |
| 2009-07-16 | Not classified | Software design | Software bug. The CELL-DYN Emerald WBC L1 flag is configured incorrectly. The flag is not generated according to system requirements. | 411 units | 2010-12-06 |
| 2009-03-27 | Not classified | Component design/selection | FIRE HAZARD– Some power supply modules may have incorrect fuses installed, which may result in fires and smoking. | 2219 units | 2011-12-21 |
| 2009-03-27 | Not classified | Component design/selection | Expanded Recall to include these additional products: FIRE HAZARD– Some power supply modules may have incorrect fuses installed, which may result in fires and smoking. | 2019 CELL-DYN 1700 and 1700CS distributed worldwide, 896 of | 2011-12-21 |
| 2009-03-27 | Not classified | Component design/selection | Expanded Recall to include these additional products: FIRE HAZARD– Some power supply modules may have incorrect fuses installed, which may result in fires and smoking. | 306 | 2011-12-21 |
| 2009-02-12 | Not classified | Device Design | Burn Risk– when power is cycled to the instrument, there is a possibility that the Mixer Motor Assembly may reach 100 degrees Celsius (212 degrees Fahrenheit ). If the customer touches the motor, burns may occur. | 324 units distributed | 2010-12-27 |
| 2008-12-10 | Not classified | Process control | Some syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe shell. | 30 syringes | 2010-12-27 |
| 2008-11-17 | Not classified | Other | Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count. | 899 units | 2010-11-27 |
| 2008-08-25 | Not classified | Device Design | Exposed wire resulted in minor electrical shock and burn to the service technician | 958 units | 2011-01-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.