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Atellica Cort Urine Recon Buffer
Siemens Healthcare Diagnostics Inc. · Model 10995540 · UDI-DI 00630414598673
1
510(k) clearances
75
Adverse events
5
Recalls
13
Facilities
Description
Cortisol Urine Reconstitution Buffer Atellica IM - CONS 1 x 60mL
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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