VITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells
ORTHO-CLINICAL DIAGNOSTICS is recalling VITROS Troponin I ES Reagent Pack due to potential incorrect wells that could generate false negative diagnostic results. Lot 4800 with expiration 10-Jun-2023 is affected.
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 that could generate false negative diagnostic results. The hazard is stated as potential with no reported illnesses or injuries, placing this at High severity per the rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
ORTHO-CLINICAL DIAGNOSTICS is recalling the VITROS Immunodiagnostic Products Troponin I ES Reagent Pack, a medical device reagent kit used in immunodiagnostic testing. The recall affects 4,013 units of Lot No. 4800 with expiration date 10-Jun-2023, distributed worldwide to the United States and Canada.
The reagent packs could potentially contain incorrect wells, which would generate incorrect and potentially false negative results. Such errors could impact the accuracy of diagnostic testing.
The recall affects hospitals, diagnostic laboratories, and other healthcare facilities using this reagent. Affected units are identified by Product Code 6802301, UDI-DI 10758750002504, and Lot No. 4800 with expiration 10-Jun-2023.
The recalled product
- Product
- VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Hazard
- incorrect-wells
- false-negative-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 (4)
- Product Code: 6802301
- UDI-DI: 10758750002504
- Lot No.: 4800
- Expiration Date: 10-Jun-2023.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighTangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
FDA (Devices) · 2026-05-27