BBL — Class II medical device recall Z-0028-2014
Terminated recall by Becton Dickinson & Co., reported 2013-10-30, distributed nationwide. An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diag
| Recall number | Z-0028-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2013-09-09 |
| Classified | 2013-10-19 |
| Reported by FDA | 2013-10-30 |
| Terminated | 2013-10-29 |
| Distributed | Nationwide (US) |
| Quantity | 187,000 tubes |
| Reason classes | labeling |
| Lot numbers | 3042466, 3053239, 3053240, 3061013, 3061014, 3070433, 3070436, 3070437 |
| Model numbers | 245122 |
Product
BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).
Reason for recall
An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false negative result.
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-0028-2014. 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.