FDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
Ortho-Clinical Diagnostics is recalling VITROS Troponin I ES Calibrators because reagent packs may contain incorrect wells that could produce false negative results. The recall affects 4,013 units distributed worldwide.
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 recall affecting a diagnostic product with risk of false negative results in cardiac troponin testing, which could delay diagnosis of serious cardiac conditions. No illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ORTHO-CLINICAL DIAGNOSTICS is recalling VITROS Immunodiagnostic Products Troponin I ES Calibrators due to a potential manufacturing defect. The recall involves 4,013 units with Lot No. 4800 (expiration date June 10, 2023) distributed worldwide, including throughout the United States and Canada (Product Code: 6802302; UDI-DI: 10758750002511).
Reagent packs in the affected calibrators could potentially contain incorrect wells. This defect could cause the calibrators to generate incorrect and potentially false negative results in troponin testing.
These diagnostic calibrators are used in clinical laboratory settings. Laboratories and healthcare facilities that received products from the affected lot should verify their inventory against the lot number and expiration date.
The recalled product
- Product
- VITROS Immunodiagnostic Products Troponin I ES Calibrators
- 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: 6802302
- UDI-DI: 10758750002511
- 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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