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Access Cortisol Calibrator S0
Beckman Coulter, Inc. · Model 33606 · UDI-DI 15099590231095
JIS
Prescription
10
510(k) clearances
39
Adverse events
21
Recalls
70
Facilities
Description
The Access Cortisol Calibrator S0 is intended for use with the Access Cortisol assay to dilute patient samples containing analyte concentrations greater than the analyte specific S5 calibrator.
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.