FDA Device recall Z-1157-2021
Gram-Negative Bacteria And Associated Resistance Markers
- FDA Device
- Class II
- terminated
- Published 2021-03-10
On 2021-03-10 the FDA classified a Class II recall of Gram-Negative Bacteria And Associated Resistance Markers by Biofire Diagnostics, citing the firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1157-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-26 |
| Published | 2021-03-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biofire Diagnostics |
| Distribution | US |
Product
Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093 IVD, Rx Only
Reason
The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
Identifiers
| code_info | All non-expired BCID and BCID2 Panel lots, if used with the BD BACTEC Culture Media vials Catalog No. 442023 and 442020. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1157-2021%22
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