Medical Device Manufacturer Recalls Quality Control Panel for Incorrect Shelf-Life
Microbiologics Inc recalls the Pneumonia (33 Targets) Control Panel due to a shelf-life discrepancy. The product's shelf-life was determined to be 6 months instead of the labeled 18 months.
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 is a labeling error involving incorrect shelf-life information on a medical device quality control material. No illnesses, injuries, or deaths have been reported, and the hazard is preventative in nature. FDA Class II classification applies, but without reported hospitalization or injury, this meets the rubric criterion for minor labeling errors.
Plain-English summary
Microbiologics Inc is recalling the Pneumonia (33 Targets) Control Panel, a quality control material used in laboratories to verify pneumonia diagnostic test accuracy. The recall affects 13 units distributed to laboratories in Alabama, Georgia, Illinois, Montana, Pennsylvania, Tennessee, Texas, and Wisconsin.
The control panel was labeled with an 18-month shelf-life, but testing determined the actual shelf-life is 6 months. The affected product is identified as Catalog Number 8244, with lot numbers 8244 01 (original expiration date 07/31/2022) and 8244 02 (original expiration date 08/31/2022).
Laboratories that have received this product should verify whether their units have exceeded the corrected 6-month shelf-life. If the product has degraded beyond the correct expiration date, it should not be used for quality control testing, as it may not accurately validate diagnostic test results.
The recalled product
- Product
- Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria
- Manufacturer
- Microbiologics Inc
- Hazard
- mislabeling
- degradation-risk
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 (3)
- Catalog Number 8244
- UDI: 70845357043664
- 8244 02 (08/31/2022) (08/02/2021)
Distribution
Distribution scope not specified by the agency.
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