# FDA recall Z-0393-2018

> **Becton Dickinson & Co.** · Class II · device recall initiated 2017-07-18.

## 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.

## Distribution

US and OUS.

## Key facts

- **Recall number:** Z-0393-2018
- **Recalling firm:** Becton Dickinson & Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-18
- **Report date:** 2018-01-31
- **Termination date:** 2018-07-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sparks, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0393-2018

## Citation

> AI Analytics. FDA recall Z-0393-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0393-2018. Source: US FDA. Licensed CC0.

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