Becton — Class II medical device recall Z-0699-2013
Terminated recall by Becton Dickinson & Co., reported 2013-01-30, distributed in AZ, CA, FL, GA, IN, KY, MA, MI…. In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and
| Recall number | Z-0699-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2012-12-13 |
| Classified | 2013-01-19 |
| Reported by FDA | 2013-01-30 |
| Terminated | 2013-06-03 |
| Distributed | AZ, CA, FL, GA, IN, KY, MA, MI, NC, NJ, NY, TN, TX, WA |
| Countries outside the US | AU, BE, BR, CA, CL, CN, CO, GT, HK, IN, JP, KR, MX, SG, TW, UY |
| Quantity | 67,820 units |
| Reason classes | microbial contamination |
| Lot numbers | 2086315, 2101435, 2104316, 2129460, 2129487, 2163211, 2163213, 2163215 |
| Model numbers | 24500 |
Product
Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological testing. The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.
Reason for recall
In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification.
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-0699-2013. 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.