Diagnostic device recall: incorrect color in package insert reading table
Biomerieux is recalling RAPID 20 E diagnostic systems because the package insert contains an incorrect color for interpreting negative CIT test results.
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: FDA Class II recall due to a labeling error in the package insert's reading table. Since no illnesses or injuries are mentioned and the issue is limited to documentation, this qualifies as Moderate severity.
Plain-English summary
Biomerieux Inc is recalling the RAPID 20 E (REF 20701), a laboratory diagnostic system designed to identify Enterobacteriaceae in approximately 4 hours. The recall affects 1,043 units that were distributed nationwide across the United States.
The product is being recalled due to an error in the package insert. Specifically, the Reading Table lists an incorrect color for interpreting negative results from the CIT (Citrate) test.
The affected lot numbers are 1008332150 (expiration 20-APR-2022) and 1008787180 (expiration 12-DEC-2022).
The recalled product
- Product
- RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 1,043
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 (4)
- Lot numbers 1008332150
- Exp. 20-APR-2022
- and 1008787180
- Exp. 12-DEC-2022
Distribution
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