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U.S. Department of Health and Human Services

Class 3 Device Recall Helix Elite Inactivated Standard

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  Class 3 Device Recall Helix Elite Inactivated Standard see related information
Date Initiated by Firm July 27, 2022
Date Posted September 14, 2022
Recall Status1 Open3, Classified
Recall Number Z-1740-2022
Recall Event ID 90761
Product Classification Multi-analyte controls unassayed - Product Code OHQ
Product Helix Elite Inactivated Standard, labeled as:

a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N;
b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
Code Information a. UDI Number: 10845357043846, Lot Number: HE0071-01-1, Expiration Date: 12/31/2022. b. UDI Number: 10845357043945, Lot Number: HE0073-02-2, Expiration Date: 02/28/2023.
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
Product not registered for use in the UK
FDA Determined
Cause 2
Process control
Action Microbiologics initially contacted the consignee via email on 07/27/2022. A formal letter was provided via email on 08/15/2022. The notification instructed the consignee to review lab procedures to understand how the recall affects their usage, discard any units depending on the lab procedures, complete and return the response form, maintain the recall letter for record, and contact Microbiologics for replacement if needed.
Quantity in Commerce 2
Distribution International distribution to the country of United Kingdom.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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