Medical Laboratory Diagnostic Media Recalled Due to Storage Condition Violations
Biomerieux Inc. is recalling PPM CLINICAL CHROMID STREPTO B diagnostic media (batch 1009534170) because storage temperature and time exceeded specified limits, preventing assurance of product performance.
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 an FDA Class II recall for a diagnostic laboratory product where storage condition exceedances prevent assurance of product performance. No illnesses or injuries have been reported. The recall presents a risk of compromised diagnostic accuracy, but without reported harm, this qualifies as a high-risk product where potential injury has not yet been reported.
Plain-English summary
Biomerieux Inc. is recalling PPM CLINICAL CHROMID STREPTO B diagnostic media, Catalog 419751 (UDI 03573026505684), Batch Number 1009534170. This product was distributed nationwide in the United States. The recalled product consists of 6 units.
The recall was initiated because the product experienced storage conditions—temperature and/or duration—that exceeded specified limits. As a result, the manufacturer states that product performance cannot be guaranteed.
PPM CLINICAL CHROMID STREPTO B is a chromogenic medium used in clinical laboratories to identify Streptococcus B. Diagnostic media exposed to improper storage conditions may yield unreliable test results, potentially affecting the accuracy of patient testing.
Laboratories and healthcare facilities that have received this batch should review their inventory and contact Biomerieux Inc. for instructions on product handling, replacement, or disposal. Additional details are available through the FDA at Recall Number Z-0847-2023.
The recalled product
- Product
- PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751
- Manufacturer
- Biomerieux Inc
- Hazard
- storage-damage
- diagnostic-failure
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 03573026505684
- Batch Numbers: 1009534170
Distribution
Distributed nationwide across the United States.
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