CLASS II Device recall · Reported 20 Jan 2021 · FDA Enforcement Report
Blood Agar/MacConkey Agar Bi-Plate recalled by Remel
Remel is recalling Blood Agar/MacConkey Agar Bi-Plate, distributed in 8 states. The recall was initiated on 10 Dec 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0769-2021
- FDA event ID
- 87010
- Recalling firm
- Remel, Lenexa, KS
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Dec 2020
- FDA classified
- 14 Jan 2021
- Reported
- 20 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 10 Dec 2020 | Recall initiated by company | |
| 14 Jan 2021 | Classified by FDA | +35 days |
| 20 Jan 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
Where it was distributed
Distribution in United States - AL, FL, GA, LA MS, NC, SC, TN
AlabamaFloridaGeorgiaLouisianaMississippiNorth CarolinaSouth CarolinaTennessee
Questions about this recall
Why was it recalled?
The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.
Which lots are affected?
Lot 150237
Where was it sold?
Distribution in United States - AL, FL, GA, LA MS, NC, SC, TN
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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