Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative d...
FDA Device Recall #Z-0572-2014 — Class II — August 27, 2013
Recall Summary
| Recall Number | Z-0572-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 27, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| Location | Jamestown, NY |
| Product Type | Devices |
| Quantity | 38 kits |
Product Description
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 for Recall
Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.
Distribution Pattern
USA Nationwide Distribution in the state of WA
Lot / Code Information
Product Code: 800-960, Lot number: 082, Model: 10 - plate kit
Other Recalls from Clark Laboratories, Inc. (dba,Trinity...
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| Z-0620-2019 | Class II | ultra2 Genesys Variants Analyzer, REF 03-01-004... | Nov 1, 2018 |
| Z-0623-2019 | Class II | Genesys 2 Reagent, REF 01-03-0022 intended to b... | Nov 1, 2018 |
| Z-0621-2019 | Class II | Genesys Analytical Column, REF 01-05-0017 inten... | Nov 1, 2018 |
| Z-0622-2019 | Class II | Genesys 1 Reagent, REF 01-03-0020 intended to b... | Nov 1, 2018 |
| Z-0624-2019 | Class II | Genesys Diluent Reagent, REF 01-03-0019 intende... | Nov 1, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.