Cardiac control material recalled over vial to vial troponin variability
Microgenics is recalling 4,462 units of Thermo Scientific MAS Omni CARDIO control after customers reported vial-to-vial variability with high sensitivity Troponin I assays.
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: Scored 3 under the risk-of-harm criterion: the firm states the defect may delay high sensitivity Troponin I results, and no injuries are reported.
Plain-English summary
Thermo Scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, an in vitro diagnostic external control, is being recalled across catalog numbers OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP and OCRD-UL.
The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. The firm states this defect may lead to a delay in patient results for hs Troponin I assays.
The recall covers 4,462 units, including lot OCRD2704U (expiring 30 April 2027), distributed worldwide including in Alabama, Oklahoma, New Hampshire, New York, Wisconsin, Illinois, Louisiana, Arkansas, Texas, Utah, Georgia and Idaho. The FDA has classified the action as Class II.
High sensitivity Troponin I is used in the assessment of suspected heart attack, so a delay in results has clinical weight. Laboratories holding affected lots should follow the firm's instructions.
The recalled product
- Product
- Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control
- Manufacturer
- Microgenics Corporation
- Affected units
- 4,462
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 (16)
- OCRD-UL: UDI/DI 00884883011946
- Lot Number OCRD2704U
- Exp 2027-04-30
- OCRD-L: UDI/DI 00884883011953
- Lot Number OCRD2704L
- OCRD-101: UDI/DI 00884883011960
- Lot Number OCRD27041
- OCRD-202: UDI/DI 00884883011977
- Lot Number OCRD27042
- OCRD-303: UDI/DI 00884883011984
- Lot Number OCRD27043
- OCRD-SP: UDI/DI 00884883011991
- Lot Number OCRD2704S
- OCRD-MP: UDI/DI 00884883012004
- Lot Number OCRD2704M
- Exp 2027-04-30.
Distribution
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