API ID 32 C Diagnostic Strips Recalled Due to Thermoforming Defect
Biomerieux is recalling API ID 32 C Strips due to a thermoforming defect that risks misidentification of yeasts or delayed diagnostic results. The recall affects 462 kits in Arizona, Iowa, Kentucky, and New York.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a diagnostic device where a thermoforming defect creates a risk of misidentification or delayed results. No illnesses or injuries have been reported. The recall qualifies as a 'risk-of-harm product where injury has not yet been reported,' meeting the High severity threshold.
Plain-English summary
Biomerieux Inc is recalling API ID 32 C Strips (Reference 32200), a diagnostic laboratory system used to identify yeasts. The product uses miniaturized tests and database-driven identification software. The recall is due to a thermoforming defect discovered in the manufacturing process.
The thermoforming defect creates a risk of misidentification of yeasts or delayed or absent identification results when the strips are used. This could impact clinical decision-making.
The affected product includes 462 kits with lot number 1008781060. Distribution was domestic, limited to healthcare facilities in Arizona, Iowa, Kentucky, and New York.
Healthcare providers with this product should contact Biomerieux Inc for recall instructions and proper return or replacement procedures.
The recalled product
- Product
- API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either…
- Manufacturer
- Biomerieux Inc
- Affected units
- 462
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 (2)
- Model No. 32200
- Lot 1008781060.
Distribution
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