Trinity Biotech Recalls Captia Syphilis-G Test Kits Due to False Negatives
Trinity Biotech is recalling Captia Syphilis-G Test Kits because they may produce false negative results for syphilis antibodies.
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: The recall involves a medical device that may produce false negative results for a serious infectious disease. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Trinity Biotech, doing business as Clark Laboratories, Inc., is recalling 38 units of the Captia Syphilis-G Test Kit. The product is an enzyme immunoassay used to detect IgG antibodies to T. pallidum in serum specimens. The recall was initiated because the test kits may produce false negative results.
The affected products are identified by Product Code 800-960, Lot number 082, and Model 10 - plate kit. These kits were distributed nationwide in the United States, specifically within the state of Washington.
Healthcare providers and laboratories should stop using the affected test kits immediately. Users should contact the recalling firm for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum (…
- Hazard
- Affected units
- 38
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 (3)
- Product Code: 800-960
- Lot number: 082
- Model: 10 - plate kit
Distribution
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