Z-0844-2022Class II

Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1...

Name: Z-0844-2022 Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1...
Creator: Microbiologics Inc
Published: 2022-03-03
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2022-03-03 / Terminated

FDA source

Microbiologics Inc began a recall of Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 -... on 2022-03-03. FDA classified it as Class II and gives the reason as "Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0844-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-03
Posted: 2022-03-31
Terminated: 2024-01-16
Recalling firm: Microbiologics, Inc.
Product: Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria
Product code: OHQ Multi-Analyte Controls Unassayed
Reason for recall: Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
FDA root cause: Incorrect or no expiration date
Action: 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 [email protected], and keep the letter for consignees' records. Questions or concerns can be directed to the Recall Support team at 320.229.7073 or [email protected].
Quantity in commerce: 13 units
Distribution: US distribution to Alabama, Georgia, Illinois, Montana, Pennsylvania, Tennessee, Texas, and Wisconsin
Product codes and 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0844-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0844-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-06	2022-03-31

Product code OHQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)