FDA Device recall Z-0139-2027
BD Phoenix Panel NMIC-312
- FDA Device
- Class II
- ongoing
- Published 2026-10-21
On 2026-10-21 the FDA classified a Class II recall of BD Phoenix Panel NMIC-312 by Becton Dickinson And, citing potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0139-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-13 |
| Published | 2026-10-21 |
| Last updated | 2026-10-27 05:30 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
Product
BD Phoenix Panel NMIC-312. Catalog Number: 449082.
Reason
Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
Identifiers
| code_info | Catalog Number: 449082. UDI Numbers: (10)5324466(17)26 1116(30)0025(01)3 0382904490820, (10)5349874(17)26 1209(30)0025…Catalog Number: 449082. UDI Numbers: (10)5324466(17)26 1116(30)0025(01)3 0382904490820, (10)5349874(17)26 1209(30)0025(01)3 0382904490820, (10)6008828(17)26 1226(30)0025(01)3 0382904490820, (10)5350977(17)26 1228(30)0025(01)3 0382904490820, (10)6028392(17)27 0120(30)0025(01)3 0382904490820, (10)6034513(17)27 0131(30)0025(01)3 0382904490820, (10)6042998(17)27 0202(30)0025(01)3 0382904490820, (10)6042021(17)27 0203(30)0025(01)3 0382904490820, (10)6056431(17)27 0217(30)0025(01)3 0382904490820, (10)6069033(17)27 0309(30)0025(01)3 0382904490820, (10)6083447(17)27 0327(30)0025(01)3 0382904490820, (10)6098295(17)27 0330(30)0025(01)3 0382904490820, (10)6104811(17)27 0412(30)0025(01)3 0382904490820, (10)6104042(17)27 0419(30)0025(01)3 0382904490820, (10)6118556(17)27 0421(30)0025(01)3 0382904490820, (10)6125526(17)27 0501(30)0025(01)3 0382904490820, (10)6128740(17)27 0503(30)0025(01)3 0382904490820, (10)6132650(17)27 0508(30)0025(01)3 0382904490820, (10)6132735(17)27 0510(30)0025(01)3 03829044 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-27 05:30 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0139-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.