VITROS performance verifier lots recalled for quality control drift
Ortho-Clinical Diagnostics is recalling certain lots of VITROS Chemistry Products Performance Verifier II due to quality control drift that may produce inaccurate laboratory results when used 2-7 days after reconstitution.
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: This is an FDA Class II recall of a quality control material where drift may produce inaccurate laboratory results and erroneous patient results. While no illnesses or injuries have been reported, the potential for erroneous patient results with positive bias represents a risk-of-harm scenario where the hazard is theoretical but not yet realized, consistent with a High severity classification.
Plain-English summary
Ortho-Clinical Diagnostics is recalling certain lots of VITROS Chemistry Products Performance Verifier II (Model 8231474), a quality control material used to verify the performance of laboratory chemistry systems. Specific lots of this product exhibit quality control drift when used 2-7 days after reconstitution, despite the product label claiming stability for 7 days following reconstitution. This drift occurs when certain lots of Performance Verifiers are used with certain lots of cholinesterase enzyme slides.
The drift may lead to inaccurate quality control results. When laboratories obtain out-of-range quality control results, they must repeat the testing, which delays patient test results. Additionally, the drift could result in erroneous patient results with a documented small positive bias in readings.
The recall affects 36,005 units distributed in the United States to AZ, CA, FL, GA, IL, MD, MI, MO, MS, NY, TN, TX, VA, and 22,302 units distributed internationally to Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, and United Kingdom. Affected lot codes with expiration dates include: W1667 (Exp. 8/14/2025), X1901 (Exp. 11/20/2025), A2114 (Exp. 3/25/2026), D2338 (Exp. 6/3/2026), and F2830 (Exp. 2/3/2027). Laboratories using this product should discontinue use of the affected lots and contact their Ortho-Clinical Diagnostics representative for replacement materials or further instructions.
The recalled product
- Product
- Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on V
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- qc-drift
- inaccurate-results
- erroneous-results
Distribution
Distributed nationwide across the United States.
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