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Alinity
Abbott GmbH · Model 09P6320 · UDI-DI 00380740150693
DFT
Prescription
10
510(k) clearances
1
Adverse events
4
Recalls
11
Facilities
Description
Alinity c Immunoglobulin M Reagent Kit 360 Tests
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-01 | Randox Laboratories Ltd. | Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX |
| 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. |
| 2005-11-10 | Abbott Laboratories Diagnostic Div | These specific protein assays are not meeting the 57-day on board stability claim |
| 2002-07-31 | Abbott Laboratories Diagnostic Div | Assay may produce falsely low IgM results without error codes when testing specimens contain elevated serum paraproteins associated with various myeloma or other malignancies. |
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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.