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hsCRP CAL
RANDOX LABORATORIES LIMITED · Model CP2478 · UDI-DI 05055273201680
JIS
Prescription
1
510(k) clearances
39
Adverse events
21
Recalls
71
Facilities
Description
The device is intended for in vitro diagnostic use in the calibration of CRP assays on clinical chemistry systems.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-15 | Siemens Healthcare Diagnostics, Inc. | Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instabili |
| 2025-04-15 | Siemens Healthcare Diagnostics, Inc. | Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instabili |
| 2024-04-09 | QUIDELORTHO | Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results |
| 2022-03-08 | Abbott Laboratories | This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the |
| 2021-07-29 | Sentinel CH SpA | Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loaded and calibration |
| 2020-12-22 | Fujifilm Medical Systems U.S.A., Inc. | FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This may result incorrect results |
| 2018-11-29 | Ortho Clinical Diagnostics Inc | A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration. |
| 2017-02-23 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) and Aspartate Aminotransferase |
| 2016-10-24 | Beckman Coulter Inc. | Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria. |
| 2013-06-28 | Siemens Healthcare Diagnostics, Inc | Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.