VITROS Chemistry Products Performance Verifier Recalled for Quality Control Drift Risk
Ortho-Clinical Diagnostics recalled certain lots of VITROS Chemistry Performance Verifier because quality control drift can cause inaccurate lab test results when used 2-7 days after reconstitution.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses, injuries, or hospitalization cases. The issue is fundamentally a quality control stability claim discrepancy (label claims 7-day stability but drift occurs at 2-7 days post-reconstitution) with no documented adverse events. This warrants Score 2 per the rubric criterion for precautionary recalls without reported harm.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling certain lots of VITROS Chemistry Products Performance Verifier I (Model 806 7324). This product is used as a quality control material to monitor performance of VITROS Chemistry laboratory systems. The affected lots are V1665 (expiring 8/14/2025), B2245 (expiring 3/25/2026), Y2110 (expiring 3/25/2026), and E2828 (expiring 2/3/2027).
The company identified a quality control drift when certain lots of the Performance Verifier are used with certain lots of cholinesterase enzyme slides. This drift occurs when the Performance Verifier is used between 2-7 days after reconstitution, despite the product label claiming stability for 7 days following reconstitution. This timing mismatch can result in inaccurate quality control test results.
If laboratories do not notice that quality control results have fallen outside their established ranges, this could lead to delayed patient results as repeat testing becomes necessary, or potentially to erroneous patient results with a small positive bias in measurements. Customers should review their quality control records for the affected lots and verify that results remain within established ranges. Any out-of-range results should prompt repeat testing using newly reconstituted materials.
No patient illnesses or injuries have been reported in connection with this issue.
The recalled product
- Product
- Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor perfo
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- qc-drift
- inaccurate-qc-results
- measurement-bias
Distribution
Distributed nationwide across the United States.
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