VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro… — Class II medical device recall Z-2671-2014
Terminated recall by ORTHO-CLINICAL DIAGNOSTICS, reported 2014-10-01, distributed in CT, FL, GA, MA, MD, NJ, NY, PA…. VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expecte
| Recall number | Z-2671-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ORTHO-CLINICAL DIAGNOSTICS, Bridgend, N/A, United Kingdom |
| Recall initiated | 2014-08-06 |
| Classified | 2014-09-19 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2017-04-14 |
| Distributed | CT, FL, GA, MA, MD, NJ, NY, PA, VA |
| Quantity | 463 sales |
| Lot numbers | 9090 |
| Model numbers | 2454, 680 |
| Expiration dates | 2014-12-15 |
Product
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- Ortho-Clinical Diagnostics High Wycombe UK. Note that one sales unit has 5 Reagent Packs contained within it. Each Reagent Pack can test for 100 samples (patient, Quality Control, etc.).
Reason for recall
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 to 66.2% which can result in unexpected negative test results being obtained for reactive sample fluids (quality control and patient samples).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2671-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.