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U.S. Department of Health and Human Services

Class 2 Device Recall Helix Elite Molecular Standards

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 Class 2 Device Recall Helix Elite Molecular Standardssee related information
Date Initiated by FirmMarch 24, 2022
Create DateApril 19, 2022
Recall Status1 Terminated 3 on January 09, 2023
Recall NumberZ-0954-2022
Recall Event ID 89886
Product Classification Multi-analyte controls unassayed - Product Code OHQ
ProductInactivated macrolide and quinolone-resistant Mycoplasma genitalium
Code Information Catalog HE0069N; Lot HE0069-02-1 UDI: 10845357043990
FEI Number 2150138
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information ContactBecky Neu
320-229-7073
Manufacturer Reason
for Recall		QC process was not adequate for the specification range.
FDA Determined
Cause 2		Process control
ActionA customer letter, dated 03/24/2022, was emailed to the impacted consignee. The consignee is instructed to destroy the product as it is now past its updated expiration date. The consignee is asked to complete the response form and submit to the recalling firm.
Quantity in Commerce1 ea
DistributionUS Nationwide distribution in the state of TX.
Total Product Life CycleTPLC 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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