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Alinity
Abbott GmbH · Model 07P4745 · UDI-DI 00380740189976
LGD
Prescription
1
510(k) clearances
1,578
Adverse events
7
Recalls
32
Facilities
Description
Alinity i Toxo IgM Reagent Kit (1000T)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-30 | Bio-Rad Laboratories, Inc. | Due to a risk of false positive results that could lead to unnecessary medical treatment. |
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed result |
| 2018-03-23 | BioMerieux SA | A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioMrieux di |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
| 2008-08-27 | Calbiotech Inc | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, |
| 2007-04-23 | Abbott Laboratories | Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent k |
| 2007-04-23 | Abbott Laboratories | Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent k |
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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.