BD Phoenix PMIC-107: IVD is intended for the in vitro rapid… — Class II medical device recall Z-0761-2021
Terminated recall by Becton Dickinson & Co., reported 2021-01-06, distributed nationwide. BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lea
| Recall number | Z-0761-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2020-12-08 |
| Classified | 2020-12-31 |
| Reported by FDA | 2021-01-06 |
| Terminated | 2023-10-03 |
| Distributed | Nationwide (US) |
| Quantity | 103,475 eaches |
| Pathogens | staphylococcus |
| UPC / GTIN / UDI-DI | 00382904484170 |
| Lot numbers | 00382904484170BD |
| Model numbers | 448417 |
Product
BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448417
Reason for recall
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection
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-0761-2021. 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.