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Elecsys Anti-HCV II
Roche Diagnostics GmbH · Model 06368921160 · UDI-DI 07613336154304
MZO
Prescription
0
510(k) clearances
1,668
Adverse events (1 deaths)
7
Recalls
23
Facilities
Description
Anti-HCV II 100-Test Kit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-04 | Abbott GmbH | Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that m |
| 2024-03-04 | Abbott GmbH | Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that m |
| 2016-01-15 | OraSure Technologies, Inc. | OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Antibody test Visual Reference Panel may be incorrect due to a complaint received from |
| 2014-08-06 | ORTHO-CLINICAL DIAGNOSTICS | VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expected VITROS Anti-HCV test results due to an approximate signal loss of up |
| 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 |
| 2006-10-06 | Home Access Health Corp (HAHC) | Wrong Expiration Date; The kits were labeled with Expiration/Use By dates; that exceed the expiration dates of the sterile safety lancet component of the kit. |
| 2004-03-09 | Diasorin Inc. | An error in the acceptance specification for the substrate blank optical density was discovered in the Bio-Tek ELx800 programming specifications for the ORTHO HCV Version 3.0 ELISA |
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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.