Z-0844-2022 Class II Terminated
FDA device recall Z-0844-2022 was initiated by Microbiologics Inc on Mar 3, 2022 and is designated Class II. Reason for recall: Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months. The recall status is terminated (terminated Jan 16, 2024). Affected quantity: 13 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 6, 2022
- Initiation Date
- Mar 3, 2022
- Termination Date
- Jan 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units
Product Description
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria
Reason for Recall
Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
Distribution Pattern
US distribution to Alabama, Georgia, Illinois, Montana, Pennsylvania, Tennessee, Texas, and Wisconsin
Code Information
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)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0844-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026