BD BBL Taxo XV Factor Strips — Class II medical device recall Z-0523-2013
Terminated recall by Becton Dickinson & Co., reported 2012-12-19, distributed nationwide. In vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives or
| Recall number | Z-0523-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2012-10-22 |
| Classified | 2012-12-13 |
| Reported by FDA | 2012-12-19 |
| Terminated | 2013-01-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, IN, JP, KR, MX, TH |
| Quantity | 650 vials |
| Lot numbers | 2089253 |
| Model numbers | 231104 |
Product
BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***
Reason for recall
In vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives or misidentification of Hemophilus species present in patient specimens.
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-0523-2013. 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.