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MP Biomedicals LLC
Mp Biomedicals, LLC · Model 07171102 · UDI-DI 00817830023150
1
510(k) clearances
7
Adverse events
3
Recalls
22
Facilities
Description
IMUCHEM DOUBLE ANTIBODY 17α-HYDROXYPROGESTERONE 125I RIA 100 TUBE KIT
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-13 | DRG International, Inc. | The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to |
| 2023-04-05 | Siemens Healthcare Diagnostics, Inc. | Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias |
| 2023-04-05 | Siemens Healthcare Diagnostics, Inc. | Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias |
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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.