SP Control 2
Catalogue number PS2683, listed by Randox Laboratories Limited, United Kingdom, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
15510(k) clearances naming this product code
28recalls on this code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Randox Laboratories Limited, United Kingdom |
|---|---|
| FDA product code | JJY |
| Device type | Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K972608 |
| Record published | 2016-09-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Special storage condition: Once opened Protein control material is stable for 30 days at +2°C to +8°C, if kept |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PS2683 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Liquichek | Bio-Rad Laboratories Inc. | 154 |
| Validate | LGC Clinical Diagnostics, Inc. | 120 |
| InteliQ | Bio-Rad Laboratories Inc. | 50 |
| Lyphochek | Bio-Rad Laboratories Inc. | 39 |
| Stat Profile | Nova Biomedical Corporation | 38 |
| i-STAT | Abbott Point OF Care Inc. | 24 |
| Multichem AE | Techno-Path Manufacturing Ltd. | 20 |
| Serum Control | Chromsystems Instruments & Chemicals Gmbh | 18 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 16 |
| Nova | Nova Biomedical Corporation | 14 |
| Plasma Control | Chromsystems Instruments & Chemicals Gmbh | 14 |
| Multichem IA Speciality | Techno-Path Manufacturing Ltd. | 12 |
Showing 12 of 559. All products under Multi-Analyte Controls, All Kinds (Assayed)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140971 | 2014-12-08 |
| K140522 | 2014-05-22 |
| K140393 | 2014-03-25 |
| K132156 | 2013-10-23 |
| K130337 | 2013-06-19 |
| K121603 | 2012-11-20 |
| K113720 | 2012-09-20 |
| K110534 | 2012-01-23 |
| K112337 | 2011-12-01 |
| K110904 | 2011-09-30 |
| K041361 | 2004-09-09 |
| K040379 | 2004-06-16 |
| K022591 | 2002-08-30 |
| K972608 | 1997-08-04 |
| K942458 | 1995-03-13 |
Recalls Naming This Product
6 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 |
|---|---|---|---|---|---|---|---|
| Randox Laboratories Limited | 510(k) number | 2022-11-22 | Class II | Under Investigation by firm | Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range | 146 units US | |
| Randox Laboratories Limited | 510(k) number | 2022-11-22 | Class II | Under Investigation by firm | Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range | 115 units | |
| Randox Laboratories Limited | 510(k) number | 2022-11-22 | Class II | Under Investigation by firm | Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range | 49 units US | |
| Randox Laboratories Limited | 510(k) number | 2018-05-22 | Class II | Under Investigation by firm | The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa Light Chains results, which are used as | 2020-11-17 | |
| Randox Laboratories Limited | 510(k) number | 2018-05-22 | Class II | Under Investigation by firm | The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa Light Chains results, which are used as | 2020-11-17 | |
| Randox Laboratories Limited | 510(k) number | 2018-05-22 | Class II | Under Investigation by firm | The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa Light Chains results, which are used as | 2020-11-17 |
Recalls
15 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-08-03 | Class II | Under Investigation by firm | there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which ma | 66 kits | |
| 2023-06-21 | Class II | Under Investigation by firm | (1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for cortisol. (3) There has been a transcription error for Creatinine in the Instructions For U | 39 units | |
| 2023-05-04 | Class III | Nonconforming Material/Component | Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has | 1 kit | |
| 2023-05-04 | Class III | Nonconforming Material/Component | Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has b | 30 kits | |
| 2020-02-18 | Class II | Under Investigation by firm | The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly. | 186 total, 27 USA | |
| 2019-12-13 | Class III | Error in labeling | A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range are listed as 50 U/L (40 – 60) and should be 72U/L (58 – 86). | 2 | 2020-10-02 |
| 2019-10-04 | Class II | Under Investigation by firm | Removal of claims for N-proBNP in the Liquid Cardiac Control model numbers CQ5051 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots. | 6,208 | 2020-07-06 |
| 2019-10-04 | Class II | Under Investigation by firm | Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5052 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots. | 7,505 | 2020-07-06 |
| 2019-10-04 | Class II | Under Investigation by firm | Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots. | 6,702 | 2020-07-06 |
| 2019-06-11 | Class II | Under Investigation by firm | The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls. | 149 (US) | 2020-05-15 |
| 2019-06-10 | Class III | Process design | The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL. | 4 kits (US) | 2020-06-16 |
| 2019-03-11 | Class II | Under Investigation by firm | Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liquid Cardiac Control lots identified, on the Siemens Dimension EXL LOCI. | 11420 kits | 2020-05-15 |
| 2019-02-13 | Class II | Process control | An error in the assignment of the control range pH in Blood Gas Control | 1 kit | 2020-04-14 |
| 2019-02-07 | Class III | Employee error | The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U. | 12 | 2020-06-08 |
| 2019-02-07 | Class III | Employee error | The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U. | 4 | 2020-06-08 |
| 2019-02-07 | Class III | Employee error | The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U. | 58 | 2020-06-08 |
| 2018-10-02 | Class II | Under Investigation by firm | Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the | 1763 | 2019-05-30 |
| 2018-10-02 | Class II | Under Investigation by firm | Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the | 1738 | 2019-05-30 |
| 2018-10-02 | Class II | Under Investigation by firm | Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the | 2108 | 2019-05-30 |
| 2018-06-08 | Class II | Under Investigation by firm | The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out of range could lead to a delay in reporting Tropon | 1 kit (US), 602 kits (OUS) | 2018-11-05 |
| 2017-08-08 | Class II | Unknown/Undetermined by firm | Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided control ranges the product | 450 kits | 2018-09-05 |
| 2016-09-16 | Class II | Nonconforming Material/Component | An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for Randox Immunoturbidimetric and Siemens Centaur Classic methods and CKMB (-21% bias) for Roche e411, BioMerieux Vidas, and Siemens Ce | 2817 | 2018-04-11 |
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.