The Recall Desk
ModerateFDA (Devices)·Z-0769-2021·Announced 2021-01-20

Remel Blood Agar Bi-Plate Recalled for Poor Microbial Growth

Remel Inc is recalling 637 units of Blood Agar/MacConkey Agar Bi-Plates because the blood agar side may fail to grow certain patient isolates or quality control organisms.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect in a laboratory diagnostic tool rather than a direct physical injury or high-risk pathogen exposure to the general public.

Plain-English summary

Remel Inc is recalling 637 units of Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049, Lot 150237. The recall is due to a defect where the blood agar side of the bi-plate may not grow some patient isolates or quality control organisms as intended.

The affected products were distributed in the United States to Alabama, Florida, Georgia, Louisiana, Mississippi, North Carolina, South Carolina, and Tennessee. The recall is classified as Class II by the U.S. Food and Drug Administration.

Users of these products should stop using the affected bi-plates and contact Remel Inc for further instructions or a replacement. This recall is limited to the specific lot number and product reference number listed above.

The recalled product

Product
Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
Manufacturer
Remel Inc
Category
Medical Device — Laboratory Diagnostic
Hazard
Affected units
637

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot 150237

Distribution

Distributed in 8 states:

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