VITROS Anti-HBs Immunodiagnostic Products Recalled for Calibration Failures
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products used to test for Hepatitis B antibodies due to potential calibration failures and falsely elevated test results affecting specific lot numbers.
What this means for you
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: FDA Class II recall for in-vitro diagnostic products with potential for inaccurate test results and calibration failures. While no illnesses or injuries are reported in the source, the defect creates risk of incorrect Hepatitis B antibody measurement, meeting the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling specific lots of VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack (Catalog No. 6801925) and Anti-HBs Calibrators (Catalog No. 6801926). These products are used in clinical laboratory testing to measure Hepatitis B antibody levels.
Affected lots may experience increased calibration failures or produce falsely elevated test results. These defects mean the diagnostic systems may not calibrate correctly or may inaccurately measure Hepatitis B antibody levels in patient samples.
The recall affects 6,920 units distributed in the United States and 57 units distributed internationally, including Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, Belgium, and The Netherlands. The affected lot numbers are 8931, 8940, 8955, 8960, 8970, 8980, and 8990.
Healthcare facilities and laboratories using affected lots should contact Ortho-Clinical Diagnostics for product replacement or return instructions.
The recalled product
- Product
- VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- calibration-failure
- false-elevated-results
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 (1)
- UDI-DI 10758750001682 Lots 8931 8940 8955 8960 8970 8980 8990
Distribution
Distributed nationwide across the United States.
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