FDA Recalls VITEK 2 AST-GP75 Test Kits for Storage Condition Violations
Biomerieux Inc recalled 218 units of VITEK 2 AST-GP75 diagnostic test kits due to storage temperature and time violations that compromise test reliability. Affected facilities should stop using the recalled kits.
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 a Class II recall of a diagnostic test kit—a risk-of-harm product where storage condition violations compromise test reliability and could result in inaccurate clinical results. No illnesses or injuries have been reported, consistent with the rubric maximum of 3 for theoretical hazards without reported harm.
Plain-English summary
Biomerieux Inc is recalling 218 units of the VITEK 2 REAGENT AST-GP75 TEST KIT (Catalog 415670) due to storage condition violations. This is an in vitro diagnostic test kit used in clinical microbiology laboratories for antimicrobial susceptibility testing, which determines bacterial susceptibility to antibiotics.
The FDA Class II recall was initiated because storage conditions—specifically temperature and time—exceeded acceptable ranges. The manufacturer cannot guarantee product performance under these circumstances, which means the reliability of test results cannot be assured.
The recall affects units distributed nationwide (UDI/DI 03573026437183, Batch Number 2752252403). Affected laboratories should immediately stop using the recalled kits and contact Biomerieux Inc for replacement options and proper disposal instructions.
The recalled product
- Product
- VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670
- Manufacturer
- Biomerieux Inc
- Affected units
- 218
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)
- UDI/DI 03573026437183
- Batch Numbers: 2752252403
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 94 recalled by Biomerieux Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 94 products in this recall →Related recalls
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