RecallRadar

FDA Device recall Z-0769-2021

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

On 2021-01-20 the FDA classified a Class II recall of Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049 by Remel, citing the blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0769-2021
ClassificationClass II
Statusterminated
Initiated2020-12-10
Published2021-01-20
Last updated2026-09-13 11:56 UTC
CompanyRemel
DistributionAL, FL, GA, LA, MS, NC, SC, TN

Product

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

Reason

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

Identifiers

code_infoLot 150237

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-0769-2021%22

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