Ortho-Clinical Diagnostics Recalls VITROS Anti-HCV Reagent Packs
Ortho-Clinical Diagnostics is recalling VITROS Anti-HCV Reagent Packs due to signal loss that may cause false negative test results for hepatitis C.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical diagnostic) where the defect can lead to false negative results for a serious condition, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 463 sales units of VITROS Immunodiagnostic Products Anti-HCV Reagent Packs (Lot 9090, exp. December 15, 2014). The product is used for the in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. Each sales unit contains 5 Reagent Packs, and each Reagent Pack can test for 100 samples.
The recall was initiated because the affected lot has been observed producing sporadic lower-than-expected test results. This is 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, including quality control and patient samples.
The recalled product was distributed in New York, New Jersey, Connecticut, Massachusetts, Pennsylvania, Virginia, Maryland, Florida, and Georgia. Users of this product should stop using the affected lot and contact Ortho-Clinical Diagnostics for further instructions.
The recalled product
- 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…
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Affected units
- 463
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 9090 (exp. December 15
- 2014)
Distribution
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