Clinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
Ortho-Clinical Diagnostics is recalling 11,224 units of VITROS Performance Verifier II due to incorrect diluent assembly, which may produce inaccurate quality control results and potentially 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: FDA Class II medical device with potential to cause patient harm through erroneous test results. No deaths, hospitalizations, or actual illnesses have been reported; the hazard is theoretical based on the assembly defect.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 11,224 units of VITROS Performance Verifier II distributed worldwide. The product is used in clinical laboratories to validate the accuracy of chemistry analyzers that produce patient test results.
The recall is due to mismatched diluent lots assembled into some units of the Performance Verifier II. This can cause the device to produce erroneous quality control results, including biased measurements of sodium and carbon dioxide levels. Without accurate quality control results, laboratories may not detect errors in their main analyzer equipment, potentially leading to testing delays and erroneous patient results.
Healthcare laboratories should identify their devices and contact Ortho-Clinical Diagnostics. The affected product lot number is R1176.
The recalled product
- Product
- VITROS Performance Verifier II
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 11,224
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: 8231474
- GTIN: 10758750004577
- Lot No. R1176.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ortho-Clinical Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Ortho-Clinical Diagnostics
See all →- HighLaboratory performance verifier recalled for mismatched diluent assembly
FDA (Devices) · 2024-04-03
- HighVITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells
FDA (Devices) · 2023-08-16
- HighFDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
FDA (Devices) · 2023-08-16
- HighOrtho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias
FDA (Devices) · 2023-07-19
- ModerateOrtho-Clinical VITROS Chemistry BuBc Slides Recalled for Etrombopag Interference
FDA (Devices) · 2020-09-02
Same hazard · erroneous test results
See all →- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- HighVITROS XT 7600 Chemistry Analyzer Software Anomaly Causing Erroneous Test Results
FDA (Devices) · 2025-07-09
- HighVITROS XT7600 System Aspiration Risk During Sample Processing
FDA (Devices) · 2024-03-13
- HighVITROS 3600 Immunodiagnostic Systems May Cause Aspiration During Sample Processing
FDA (Devices) · 2024-03-13
- HighMedical Device Reagent Recalled for Unreliable Test Results
FDA (Devices) · 2023-11-22