Home › ABBOTT LABORATORIES › Alinity
Alinity
ABBOTT LABORATORIES · Model 08P5820 · UDI-DI 00380740135331
KLT
Prescription
1
510(k) clearances
54
Adverse events
5
Recalls
19
Facilities
Description
Alinity c Carbamazepine Reagent Kit 400 Test
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-03-05 | Ortho-Clinical Diagnostics | The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403. |
| 2013-06-12 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. VITROS CRBM Slides quantitatively me |
| 2005-05-26 | Ortho-Clinical Diagnostics | Falsely elevated Carbamazepine results. |
| 2003-11-17 | Abbott Laboratories HPD/ADD/GPRD | The package inserts contain incorrect values for the alternate unit (mol/L) Control Ranges |
| 2003-06-11 | Beckman Coulter Inc | Product was found to produce higher recoveries by about 7-12% compared to other lots. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.