QC Sets and Panels: Helix Elite recallZ-0844-2022 · Microbiologics Inc · initiated Mar 3, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Microbiologics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
FDA root cause category: Incorrect or no expiration date
What the company is doing
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].
Recall details
- Recall number
- Z-0844-2022
- Status
- Terminated
- Initiated by the company
- Mar 3, 2022
- Recalling firm
- Microbiologics Inc
- Quantity
- 13 units
- Product code
- OHQ
- Distribution
- US distribution to Alabama, Georgia, Illinois, Montana, Pennsylvania, Tennessee, Texas, and Wisconsin
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
Code information (models, lots, serial numbers)
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)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- QC Sets and Panels: Helix Elite™ 8244Microbiologics Inc. · Multi-Analyte Controls Unassayed1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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