Trinity Biotech Captia Measles IgM Test Kit Recalled for QC Failure
Clark Laboratories is recalling specific lots of the Captia Measles IgM test kit because the product failed quality control stability testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a quality control failure affecting test validity rather than a direct physical hazard.
Plain-English summary
Clark Laboratories, Inc. (dba Trinity Biotech USA) is recalling the Trinity Biotech Captia Measles IgM, REF/Product Code 2326060, Test Kit for 96 Determinations. The recall affects Lot Number 2326060-043 with an expiration date of 31 May 2017. The company has identified 6 kits distributed in the United States and 50 kits distributed in China (Hong Kong).
The recall was initiated because the product lot failed to meet quality control acceptance criteria during stability testing. Specifically, the Calibrator OD was dropping, which caused the positive control to be invalid and run high out of range. This defect may affect the reliability of the test results.
The product was distributed nationwide in the United States, including California, as well as in China (Hong Kong). Users of the affected test kits should stop using the product and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
- Hazard
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 (2)
- Lot Number 2326060-043
- Expiration Date 31 May 2017
Distribution
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