FDA Device recall Z-0844-2022
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Posit…
- FDA Device
- Class II
- terminated
- Published 2022-04-06
On 2022-04-06 the FDA classified a Class II recall of Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Posit… by Microbiologics, citing shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0844-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-03 |
| Published | 2022-04-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Microbiologics |
| Distribution | AL, GA, IL, MT, PA, TN, TX, WI |
Product
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria
Reason
Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
Identifiers
| code_info | Catalog Number 8244, UDI: 70845357043664, Lot Number (Expiration Date) (New Expiration Date): 8244 01 (07/31/2022) (07/…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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0844-2022%22
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