Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria
Hazard
Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
What You Should Do
Remedy
Microbiologics notified customers on 03/03/2022 via letter titled "Urgent Medical Device Recall Re: 8244 Pneumonia (33 Targets) Control Panel". Instructions included to review lab procedures to understand how the information affects usage, discard expired product, complete the response form provided, return the response form to recall@microbiologics.com, and keep the letter for consignees' records. Questions or concerns can be directed to the Recall Support team at 320.229.7073 or recall@microbiologics.com.
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Products
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing:
Positive Control 1 - Semi-Quantitative Bacteria
Positive Control 2 - Viruses and Atypical Bacteria
- Brand
- Microbiologics Inc
- UPC
- Catalog Number 8244, UDI: 70845357043664, Lot Number (Expiration Date) (New Expiration Date): 8244 01 (07/31/2022) (07/26/2021), 8244 02 (08/31/2022) (08/02/2021)
Units Affected
13 units