Anti-SARS-CoV-2 IgG Reagent: Stability Time Overstated in Instructions
Ortho-Clinical Diagnostics is recalling Anti-SARS-CoV-2 IgG Quantitative Reagent Pack because the Instructions For Use incorrectly state on-analyzer stability of 8 weeks when the actual supported time is 6 weeks.
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 with no reported illnesses or injuries. The labeling discrepancy (8 weeks stated vs. 6 weeks actual on-analyzer stability) creates a risk of inaccurate test results if the reagent is used beyond its actual stability window, meeting the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling Anti-SARS-CoV-2 IgG Quantitative Reagent Pack (Product Code 6199960), intended for use on VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems. The recall affects 20,858 units distributed worldwide.
The Instructions For Use (IFU) incorrectly state the reagent's On-Analyzer Stability (OAS) time as 8 weeks. The actual supported on-analyzer stability time is 6 weeks. If used beyond the actual 6-week stability window, the reagent may produce inaccurate test results.
Affected reagent packs have been distributed to the United States, Colombia, India, and Singapore. The recall covers all expired, in-date, and future released lots (UDI-DI: 10758750034413).
The recalled product
- Product
- Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- labeling-error
- test-inaccuracy
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)
- UDI-DI :10758750034413. All expired
- in-date and future released lots
Distribution
Distributed nationwide across the United States.
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