FDA Device recall Z-0572-2014
Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in s…
- FDA Device
- Class II
- terminated
- Published 2014-01-01
On 2014-01-01 the FDA classified a Class II recall of Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in s… by Clark Laboratories Dba Trinity Biotech Usa, citing trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0572-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-27 |
| Published | 2014-01-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Clark Laboratories Dba Trinity Biotech Usa |
| Distribution | US |
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 ( the agent of syphilis). It is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.
Reason
Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.
Identifiers
| code_info | Product Code: 800-960, Lot number: 082, Model: 10 - plate kit |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All Clark Laboratories Dba Trinity Biotech Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0572-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.