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.
What this means for you
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.
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