RecallRadar

FDA Device recall Z-0844-2022

Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Posit…

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

AgencyFDA Device
Recall numberZ-0844-2022
ClassificationClass II
Statusterminated
Initiated2022-03-03
Published2022-04-06
Last updated2026-09-13 11:56 UTC
CompanyMicrobiologics
DistributionAL, 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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