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Atellica IM CpS
Siemens Healthcare Diagnostics Inc. · Model 10995541 · UDI-DI 00630414600413
10
510(k) clearances
19
Adverse events
5
Recalls
36
Facilities
Description
C-Peptide (CpS) Atellica IM - RGT 100T
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-12-21 | DRG International, Inc. | ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible |
| 2020-04-01 | Abbott Laboratories | Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtai |
| 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. |
| 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. |
| 2011-07-11 | Abbott Laboratories | C-Peptide lots 03610K000 and 01711A000 have the potential to generate falsely elevated results with certain patient samples and with non-Abbott Controls. |
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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.