BD MAX" UVE Specimen Collection Kit — Class II medical device recall Z-0393-2018
Terminated recall by Becton Dickinson & Co., reported 2018-01-31. BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate
| Recall number | Z-0393-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2017-07-18 |
| Classified | 2018-01-19 |
| Reported by FDA | 2018-01-31 |
| Terminated | 2018-07-09 |
| UPC / GTIN / UDI-DI | 30382904433766 |
| Model numbers | 442970, 443376, 443712, 443824 |
Product
BD MAX" UVE Specimen Collection Kit. Catalog Number(s): 443376 for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
Reason for recall
BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some customers. A non-reportable result may lead to repeat of the test and/or re-collection of a specimen.
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-0393-2018. 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.