Whole Blood Primer
2 catalogue numbers from 270-0352, listed by Bio-Rad Laboratories Inc., United States, under Assay, Glycosylated Hemoglobin. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
2catalogue numbers in this listing
8510(k) clearances naming this product code
29recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Biohermes BIO & Medical Technology Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 3 |
| Shanghai Medconn Medical Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
| Shanghai Medconn Biotechnology Co., Ltd. | Jinshan District | Shanghai | Manufacturer | 2 |
Record
| Listed by | Bio-Rad Laboratories Inc., United States |
|---|---|
| FDA product code | LCP |
| Device type | Assay, Glycosylated Hemoglobin |
| Device class | Class 2 |
| Regulation | 21 CFR 864.7470 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K040872 |
| Record published | 2016-09-12 |
| Record revised | 2023-01-31 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 270-0352 | In distribution | |
| 220-0148 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trinity Biotech | Primus Corp. | 36 |
| Variant II Turbo | Bio-Rad Laboratories Inc. | 15 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 11 |
| Variant II Turbo Link | Bio-Rad Laboratories Inc. | 7 |
| D-10 | Bio-Rad Laboratories Inc. | 7 |
| Variant II Hemoglobin A1c | Bio-Rad Laboratories Inc. | 5 |
| Drew Scientific | Drew Scientific, Ltd. | 5 |
| Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | Tosoh Corp. | 4 |
| D-100 | Bio-Rad Laboratories Inc. | 4 |
| Fructosamine | Roche Diagnostics Gmbh | 4 |
| D-10 Dual | Bio-Rad Laboratories Inc. | 3 |
| JAS Diagnostics | Drew Scientific, Ltd. | 3 |
Showing 12 of 134. All products under Assay, Glycosylated Hemoglobin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140801 | 2014-06-25 |
| K090699 | 2009-07-27 |
| K070452 | 2007-05-07 |
| K063400 | 2006-12-01 |
| K060001 | 2006-01-20 |
| K041444 | 2004-06-09 |
| K040872 | 2004-04-15 |
| K031043 | 2003-08-27 |
Recalls Naming This Product
15 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Bio-Rad Laboratories Inc. | 510(k) number | 2014-02-27 | Class II | Nonconforming Material/Component | On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample. | 483 instruments in US. OUS to be determined. | 2014-06-04 |
| Bio-Rad Laboratories Inc. | 510(k) number | 2013-11-22 | Class III | Software design | D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Hemoglobin Testing System. | 2906 kits (318 Kits in US; 2588 kits internationally) | 2014-03-20 |
| Bio-Rad Laboratories Inc. | 510(k) number | 2011-09-12 | Not classified | Process control | A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these produc | 1612 | 2012-05-11 |
| Bio-Rad Laboratories Inc. | 510(k) number | 2011-09-12 | Not classified | Process control | A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these produc | 20 | 2012-05-11 |
| Bio-Rad Laboratories Inc. | 510(k) number | 2011-09-12 | Not classified | Process control | A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these produc | 2012-05-11 | |
| Bio-Rad Laboratories Inc. | 510(k) number | 2011-09-12 | Not classified | Process control | A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these produc | 82 | 2012-05-11 |
| Bio-Rad Laboratories Inc. | 510(k) number | 2011-09-12 | Not classified | Process control | A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these produc | 273 lot number 7021066; 301 lot number 70211068. | 2012-05-11 |
| Bio-Rad Laboratories Inc. | 510(k) number | 2011-09-12 | Not classified | Process control | A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these produc | 2012-05-11 | |
| Bio-Rad Laboratories Inc. | 510(k) number | 2011-09-12 | Not classified | Process control | A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these produc | 120 | 2012-05-11 |
| Bio-Rad Laboratories Inc. | 510(k) number | 2011-09-12 | Not classified | Process control | A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these produc | 40 | 2012-05-11 |
| Bio-Rad Laboratories Inc. | 510(k) number | 2011-07-28 | Not classified | Employee error | The Elution Buffer B, lot no. GA 10430, was shipped in a 2.0 L bottle instead of the standard 2.5 L bottle. | 40 | 2011-11-01 |
| Bio-Rad Laboratories Inc. | 510(k) number | 2011-07-11 | Not classified | Other | Reports of calibration failure and late retention time using Elution Buffer AA10434 and AA10435. | 418 | 2012-03-12 |
| Bio-Rad Laboratories Inc. | 510(k) number | 2010-09-08 | Not classified | Other | The firm discovered that the Update Kit Floppy Diskette included in the reorder pack was mislabeled with an incorrect Lot Number for the Calibrator/Diluent Set as: S01819; The correct Lot Number for the Calibrator/Diluent Set is: S01704. | 2011-06-29 | |
| Bio-Rad Laboratories Inc. | 510(k) number | 2010-03-24 | Not classified | Other | The firm received customer complaints associated with the Update Kit CD-ROM not being able to generate a valid calibration after being uploaded, resulting in patient results not being generated. | 48 units | 2011-03-04 |
| Bio-Rad Laboratories Inc. | 510(k) number | 2010-02-19 | Not classified | Nonconforming Material/Component | The results from the blood device had the occurrence of some ramping baselines on their chromatograms. The ramping baseline can affect quantitation of the blood results. | 27 | 2011-03-03 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2015-12-15 | Class II | Software design | On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration. | 165 in US, 200 Internationally | 2016-05-02 |
| 2011-09-12 | Not classified | Process control | A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these produc | 491 lot 70210674; 298 lot 70210954; 136 lot 70010957 | 2012-05-11 |
| 2011-09-12 | Not classified | Process control | A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these produc | 2012-05-11 | |
| 2011-09-12 | Not classified | Process control | A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these produc | 22 | 2012-05-11 |
| 2010-09-07 | Not classified | Component design/selection | Test Cartridges may leak and have the potential to generate error messages and biased inaccurate results. | 4056 | 2011-05-17 |
| 2010-07-26 | Not classified | Device Design | Inaccurate results with high bias– Inaccurate results may be read by the machine, creating the risk for untreated hypoglycemia at elevated altitudes. | 90703 | 2011-10-25 |
| 2009-12-08 | Not classified | Other | Wrong lot number was found on the Hemoglobin Cartridge Insert. The insert did not match the lot number to the device cartridge or the device cartridge label or on the Update Kit CD. | 51 kits (Lot # 70292242; 45 kits( Lot # 70292318) | 2011-06-29 |
| 2009-12-01 | Not classified | Software change control | Some customers have reported the occurrence of some ramping baselines on the chromatograms. The ramping baseline can affect hemoglobin test results. | 1099 | 2011-08-30 |
| 2009-10-12 | Not classified | Other | Product update kit CD rom will not upload. As a result, the device cannot be run. | 21 kits | 2010-12-17 |
| 2009-06-15 | Not classified | Other | Calibration Failure– due to high intercept values, the device fails calibration and users are unable to run samples. | 613 units | 2011-02-02 |
| 2009-01-22 | Not classified | Software design | Sample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position. | 2011-03-22 | |
| 2009-01-22 | Not classified | Software design | Sample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position. | 2011-03-22 | |
| 2008-12-09 | Not classified | Pending | The wrong barcode number and tube position number may be assigned to samples leading to discrepant sample results. | 42 units | 2010-11-12 |
| 2008-10-17 | Not classified | Pending | Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results. | 92 units | 2010-11-12 |
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.