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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 4,013
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.
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
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