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U.S. Department of Health and Human Services

Class 2 Device Recall Helix Elite

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  Class 2 Device Recall Helix Elite see related information
Date Initiated by Firm March 03, 2022
Create Date March 31, 2022
Recall Status1 Terminated 3 on January 16, 2024
Recall Number Z-0844-2022
Recall Event ID 89746
Product Classification Multi-analyte controls unassayed - Product Code OHQ
Product 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 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)
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information Contact Becky Neu
320-229-7073
Manufacturer Reason
for Recall		 Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
FDA Determined
Cause 2		 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 recall@microbiologics.com, and keep the letter for consignees' records. Questions or concerns can be directed to the Recall Support team at 320.229.7073 or recall@microbiologics.com.
Quantity in Commerce 13 units
Distribution US distribution to Alabama, Georgia, Illinois, Montana, Pennsylvania, Tennessee, Texas, and Wisconsin
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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