Medical Device Reagent Recall Due to Storage Condition Exceedance
Biomerieux is recalling DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 reagent kits because temperature and time storage conditions were exceeded, preventing performance guarantees. Distributed nationwide, affected units should be removed from service.
What this means for you
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 FDA medical device recall involving a storage failure that compromises product performance. Although no illnesses or injuries have been reported, a diagnostic reagent unable to guarantee performance represents a risk-of-harm scenario where test result accuracy could be affected, potentially impacting clinical decisions.
Plain-English summary
Biomerieux Inc is recalling DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), catalog 306-R1026-01, due to improper storage conditions. Batch 3073090 exceeded specified temperature and time storage parameters, which means the product's performance cannot be guaranteed.
This reagent kit is used in laboratory diagnostic testing systems. When storage conditions fall outside specification, the chemical integrity and performance of the reagent may be compromised, potentially affecting test result accuracy and reliability.
The affected product was distributed nationwide in the United States. Facilities that received this batch should immediately discontinue use and quarantine the product. Contact Biomerieux Inc for handling and return instructions regarding the recalled units.
The recalled product
- Product
- DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01
- Manufacturer
- Biomerieux Inc
- Hazard
- performance-failure
- improper-storage
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 03661901000857
- Batch Numbers: 3073090
Distribution
Distributed nationwide across the United States.
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