Trinity Biotech Captia Syphilis IgM Test Kit Recalled for Stability Failure
Clark Laboratories is recalling the Captia Syphilis IgM Capture Test Kit because it failed to meet its labeled expiry dating during routine stability monitoring.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a stability failure regarding expiry dating, with no reported injuries or illnesses.
Plain-English summary
Clark Laboratories, Inc. (dba Trinity Biotech USA) is recalling the Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935. The recall involves Lot 033, which has an expiry date of 30 November 2014.
The firm identified the need for the recall through in-house routine real-time stability monitoring. The monitoring revealed that the test kit failed to meet its labeled expiry dating of 6 months. The affected product is an antibody class capture enzyme immunoassay used for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.
The recall covers 9 kits distributed domestically in New York, Florida, Utah, and California, and 26 kits distributed to Spain and France. The source text does not specify instructions for consumers or healthcare providers regarding the disposition of the recalled kits.
The recalled product
- Product
- Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of…
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 033
- expiry date 30 November 2014
Distribution
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