FDA Device recall Z-2671-2014
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus…
- FDA Device
- Class II
- terminated
- Published 2014-10-01
On 2014-10-01 the FDA classified a Class II recall of VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus… by Ortho Clinical Diagnostics, citing 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 u….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2671-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-06 |
| Published | 2014-10-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | CT, FL, GA, MA, MD, NJ, NY, PA, VA |
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
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).
Identifiers
| code_info | Lot 9090 (exp. December 15, 2014) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2671-2014%22
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