Diagnostic Test Kit Recalled Due to Exceeded Storage Conditions
Biomerieux Inc is recalling API STAPH 25 diagnostic test kits because storage conditions exceeded safe temperature and time parameters. Product performance cannot be guaranteed for the affected batch.
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: This FDA Class II recall is precautionary in nature, addressing storage conditions that exceeded manufacturer specifications. No illnesses, injuries, or confirmed product failures have been reported, qualifying this as a voluntary precautionary recall.
Plain-English summary
Biomerieux Inc is recalling API STAPH 25 STRIPS+25 MEDIA, a diagnostic test kit used to identify Staphylococcus bacteria in clinical laboratories. The affected product is Batch Number 1009395530 (UDI 03573026048259), which was distributed nationwide in the United States.
The recall was initiated because product storage conditions exceeded safe temperature and time parameters. As a result, the manufacturer cannot guarantee the diagnostic performance and reliability of the affected product.
No illnesses, injuries, or confirmed product failures have been reported in connection with this recall.
The recalled product
- Product
- API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500
- Manufacturer
- Biomerieux Inc
- Affected units
- 1
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 03573026048259
- Batch Number 1009395530
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
Same manufacturer · Biomerieux Inc
See all →- HighBiomerieux VITEK 2 AST-N461 Test Kit Recalled for Card Pouch Damage
FDA (Devices) · 2026-09-30
- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
- HighSusceptibility test cards recalled over false resistant antibiotic results
FDA (Devices) · 2026-02-11
- HighAntimicrobial susceptibility test cards recalled over false colistin resistance results
FDA (Devices) · 2025-10-08
- SevereVITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk
FDA (Devices) · 2024-05-01
Same hazard · product performance
See all →- ModerateBiomerieux BIOBALL P.AERUGINOSA Quality Control Product Recalled for Temperature Excursion
FDA (Devices) · 2023-01-11
- HighFDA Recalls VITEK 2 Antibiotic Susceptibility Test Kits Due to Storage Excursion
FDA (Devices) · 2023-01-11
- ModerateMicrobiological susceptibility test strips recalled for temperature and time excursion
FDA (Devices) · 2023-01-11
- ModerateOsteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error
FDA (Devices) · 2020-06-10
- ModerateOsteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error
FDA (Devices) · 2020-06-10
Similar recalls
- HighAPI 50 CH Diagnostic Test Kit Recall: Potential Organism Misidentification
FDA (Devices) · 2021-11-24
- SevereBiomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards for Labeling Error
FDA (Devices) · 2016-05-18
- ModerateDiagnostic substrate error in medical testing device causes test failures
FDA (Devices) · 2022-01-05
- LowBiomerieux Recalls Vitek 2 Gram Positive Susceptibility Cards Due to Labeling Error
FDA (Devices) · 2015-04-15
- HighBiomerieux VITEK 2 AST-N461 Test Kit Recalled for Card Pouch Damage
FDA (Devices) · 2026-09-30
- SevereBiomerieux Vitek 2 Gram Positive Susceptibility Test Cards Recalled for Labeling Error
FDA (Devices) · 2016-05-18