VITROS Chemistry CHE Slides Recalled for Quality Control Drift Risk
Ortho-Clinical Diagnostics recalls VITROS Chemistry CHE Slides due to quality control drift occurring 2-7 days after reagent reconstitution, despite labels claiming 7-day stability. This may result in inaccurate and erroneous patient test results.
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 FDA Class II recall involves diagnostic equipment with potential to produce erroneous patient results. Per the severity rubric, diagnostic products presenting risk of patient harm without reported illness qualify as High severity.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products CHE Slides (catalog numbers 684 4074 and 684 4138). The recall affects all lots within expiry, with approximately 414,000 units distributed worldwide.
Quality control drift occurs when certain lots of Performance Verifiers are used with certain lots of CHE slides 2-7 days after reconstitution, despite product labels claiming 7-day stability. This may lead to inaccurate quality control results.
Inaccurate quality control results could delay patient testing by requiring repeated testing or reconstitution of reagents. The drift could also result in erroneous patient results, specifically a small positive bias.
The recalled product
- Product
- VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- test-inaccuracy
- positive-bias
- delayed-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 (5)
- Catalog Numbers: (1) 684 4074 (90 slides)
- (2) 684 4138 (300 slides)
- UDI-DI: (1) 10758750030293
- (2) 10758750030309
- Lot Numbers: All lots within expiry.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03