Recall Z-0844-2022
Microbiologics Inc · initiated March 3, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria
Codes / lots: 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)
Reason for recall
Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
FDA-determined cause: Incorrect or no expiration date
Action taken
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.
Details
- Recall number
- Z-0844-2022
- Initiated
- March 3, 2022
- Terminated
- January 16, 2024
- Product code
- OHQ – Multi-Analyte Controls Unassayed
- Quantity
- 13 units
- Distribution
- US distribution to Alabama, Georgia, Illinois, Montana, Pennsylvania, Tennessee, Texas, and Wisconsin
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN