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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- 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
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