Medical Diagnostic Slides Recalled for Quality Control Drift
Ortho-Clinical Diagnostics recalls VITROS Chemistry CHE Slides due to quality control drift in certain lots that may produce inaccurate test results when used within the labeled stability period.
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 medical diagnostic device recall where documented quality control drift can lead to erroneous patient diagnostic results (small positive bias). Although no injuries have been reported, this constitutes a risk-of-harm product where injury has not yet been reported, per rubric Score 3 criterion.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CHE Slides (Catalog Numbers 191 4605 and 800 4707) due to quality control drift affecting certain lots. The recall applies to slides distributed nationwide in the United States and internationally to multiple countries.
The issue occurs when certain lots of Performance Verifiers are used with certain lots of CHE slides between 2 and 7 days after reconstitution. Although the product labeling claims stability for 7 days following reconstitution, quality control drift occurs within this claimed stability period. This drift can produce inaccurate quality control results.
Inaccurate quality control results may lead to delayed patient test results, as laboratories must repeat quality control testing or reconstitute new Performance Verifier fluids and retest. Alternatively, inaccurate quality control results could allow erroneous patient diagnostic results to pass quality control checks, resulting in small positive bias in reported diagnostic values. Healthcare facilities should contact Ortho-Clinical Diagnostics for guidance on identifying affected inventory and determining appropriate corrective actions.
The recalled product
- Product
- VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- quality-control-drift
- patient-result-error
- measurement-bias
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 (5)
- Catalog Numbers: (1) 191 4605 (300 slides)
- (2) 800 4707 (90 slides)
- UDI-DI: (1) 10758750000241
- (2) 10758750004225
- Lot Numbers: All lots within expiry.
Distribution
Distributed nationwide across the United States.
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