BBL CrystaLEAD Enteric/Nonfermentor — Class III medical device recall Z-2041-2014
Terminated recall by Becton Dickinson & Co., reported 2014-07-23, distributed nationwide. A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 3224281 and 3290
| Recall number | Z-2041-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2014-05-21 |
| Classified | 2014-07-11 |
| Reported by FDA | 2014-07-23 |
| Terminated | 2016-08-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CN, CO, ID, IN, JP, KR, MX, MY, PE, PH, SG, TH, TW |
| Quantity | 18.21 |
| Reason classes | labeling |
| Lot numbers | 2014/06/09, 2014/07/24, 3224281, 3290379 |
| Model numbers | 245000 |
Product
BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic 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
A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 3224281 and 3290379 are labeled with incorrect expiration dates. A portion of these kits contain Crystal Inoculum fluid bottles that will expire prior to the date that was printed on the kit carton. The expiration date printed on the individual Crystal Inoculum fluid bottles is correct.
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-2041-2014. 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.