Microbiologics Inc Recall 89746
Description: Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria
Microbiologics Inc Recall 89746 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0844-2022 |
| Event ID | 89746 |
| Event Description | Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria |
| Product Type | Devices |
| Distribution | US distribution to Alabama, Georgia, Illinois, Montana, Pennsylvania, Tennessee, Texas, and Wisconsin |
| Quantity | 13 units |
| Recall Reason | Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months. |
| Device Classification | 20220406 |
| Device Code Info | 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) |
| Center Classification Date | 20220331 |
| Recall Initiation Date | 20220303 |
| Recalling Firm | Microbiologics Inc |
| Initial Notification | Letter |
| Similar To |