FDA Device recall Z-1513-2018
FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when…
- FDA Device
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when… by Biofire Diagnostics, citing there is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1513-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-14 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biofire Diagnostics |
| Distribution | US |
Product
FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.
Reason
There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.
Identifiers
| code_info | All lot numbers are involved. UDI: 00815381020086 (RFIT-ASY-0126), 00815381020093 (RFIT-ASY-0127). The expiration d…All lot numbers are involved. UDI: 00815381020086 (RFIT-ASY-0126), 00815381020093 (RFIT-ASY-0127). The expiration dates of the BD BACTEC Blood Culture Bottles are 9/30/2018 and beyond. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1513-2018%22
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