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ARCHITECT
ABBOTT IRELAND · Model 09D9924 · UDI-DI 00380740169909
DEW
Prescription
10
510(k) clearances
71
Adverse events
4
Recalls
25
Facilities
Description
Immunoglobulin G 388 tests
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-31 | Beckman Coulter Inc. | Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU |
| 2018-05-16 | Abbott Laboratories, Inc | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products. |
| 2010-06-28 | Beckman Coulter Inc. | The recall was initiated after Beckman Coulter Inc. confirmed reports of high recovery of immunoglobulin A (IgA) in proficiency surveys or patient samples using Synchron Ig-A reage |
| 2003-06-06 | Beckman Coulter Inc | low level IgM serum sample results may be suppressed and an error code generated when using affected lots. Error codes are seen as E60 or E66. |
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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.