Laboratory performance verifier recalled for mismatched diluent assembly
Ortho-Clinical Diagnostics is recalling 10,911 units of VITROS Performance Verifier I worldwide due to mismatched diluent components that could cause inaccurate quality control 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: FDA Class II recall of a laboratory diagnostic device with potential for erroneous test results and patient harm. No illnesses or injuries have been reported, placing this in the High-severity risk-of-harm category per the rubric.
Plain-English summary
VITROS Performance Verifier I is a laboratory quality control device used to validate the accuracy of chemistry analyzers. Ortho-Clinical Diagnostics has recalled 10,911 units worldwide due to mismatched diluent components assembled into the product. The same manufacturing issue affects the Performance Verifier II model.
The mismatched diluents can produce erroneous quality control results, potentially leading to testing delays and inaccurate patient results. The error causes positive or negative bias in measurements of sodium (Na+) and total carbon dioxide (ECO2), with potential negative bias up to 6 mmol/L for these tests.
Lot Q1174 is affected. The product has been distributed worldwide.
The recalled product
- Product
- VITROS Performance Verifier I
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- erroneous-test-results
- diluent-mismatch
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 (3)
- Product Code: 8067324
- GTIN: 10758750004317
- Lot No. Q1174.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
- ModeratePhilips Allura X-ray Systems Deaeration Hose Degradation Recall
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula vascular catheter sterile barrier breach
FDA (Devices) · 2026-05-27
- ModerateOneLIF Interbody Cage Inserter Attachment Failure Recall
FDA (Devices) · 2026-05-27