Drug recall
Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG…
FDA recall event 66916 · Class II · Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Key facts
| Event ID | 66916 |
|---|---|
| Recall numbers | Z-0572-2014 |
| Recalling firm | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results. |
| Initiation date | Aug 27, 2013 |
| Report date | Jan 1, 2014 |
| Termination date | May 24, 2016 |
| City | Jamestown |
| State | NY |
| Country | United States |
| FEI number | 1318354 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: