BD Viper LT System — Class II medical device recall Z-1816-2015
Terminated recall by Becton Dickinson & Co., reported 2015-06-24. Potential for false positive Chlamydia trachomatis (CT) results and Neisseria gonorrhoeae (GC) results when pr
| Recall number | Z-1816-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2014-11-07 |
| Classified | 2015-06-18 |
| Reported by FDA | 2015-06-24 |
| Terminated | 2016-05-09 |
| Countries outside the US | AT, CN, FR, GB, HK |
| Quantity | 7 viper |
| Serial numbers | VLT0001, VLT0015, VLT0016, VLT0023, VLT0026, VLT0033, VLT0040 |
| Model numbers | 442839, 442842, 442959 |
Product
BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.
Reason for recall
Potential for false positive Chlamydia trachomatis (CT) results and Neisseria gonorrhoeae (GC) results when processing the CT Qx and GC Qx Assays on the BD Viper LT Instrument.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1816-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.