RecallRadar

FDA Device recall Z-0839-2023

PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012

On 2023-01-11 the FDA classified a Class II recall of PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012 by Biomerieux, citing as the temperature and time out of range was exceeded, product performances cannot be guaranteed.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0839-2023
ClassificationClass II
Statusongoing
Initiated2022-11-09
Published2023-01-11
Last updated2026-09-13 11:56 UTC
CompanyBiomerieux
DistributionUS

Product

PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012

Reason

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Identifiers

code_infoUDI/DI 03573026409913 , Batch Numbers: 2147080

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0839-2023%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.