FDA recall Z-0769-2021

Remel Inc · Class II · device

Product

Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049

Reason for recall

The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.

Distribution

Distribution in United States - AL, FL, GA, LA MS, NC, SC, TN

Key facts

Status
Terminated
Initiation date
2020-12-10
Report date
2021-01-20
Termination date
2023-07-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lenexa, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0769-2021