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AIA-PACK CORT Calibrator Set
TOSOH CORPORATION · Model N/A · UDI-DI 04560189211698
10
510(k) clearances
75
Adverse events
5
Recalls
13
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-16 | Siemens Healthcare Diagnostics, Inc. | There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low. |
| 2023-03-16 | Siemens Healthcare Diagnostics, Inc. | There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low. |
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. |
| 2012-03-06 | Siemens Healthcare Diagnostics, Inc | Cortisol Assay reagent kit lots do not meet onboard stability and calibration interval claims |
| 2004-02-16 | Abbott Laboratories HPD/ADD/GPRD | The package inserts contain incorrect control values for the urinary free cortisol extraction procedure. |
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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.