Recall record at a glance
| Official record | Z-2671-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | ORTHO-CLINICAL DIAGNOSTICS |
| Report date | Oct 1, 2014 |
| Recall initiation date | Aug 6, 2014 |
| Quantity | 463 sales units |
| Location | Bridgend, N/A, United Kingdom |
Official product description
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.).
Why the product was recalled
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).
Distribution information
NY, NJ, CT, MA, PA, VA, MD, FL and GA
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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