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U.S. Department of Health and Human Services

Class 2 Device Recall Helix Elite Inactivated Standard

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 Class 2 Device Recall Helix Elite Inactivated Standardsee related information
Date Initiated by FirmFebruary 20, 2025
Date PostedMarch 14, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1371-2025
Recall Event ID 96382
Product Classification Multi-analyte controls unassayed - Product Code OHQ
ProductHelix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Code Information UDI-DI: 10845357043563; Lot Number: HE0065-29
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information ContactRebecca Neu
320-229-7080
Manufacturer Reason
for Recall		The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
FDA Determined
Cause 2		Process control
ActionAn Urgent Medical Device Recall notification letter dated 2/20/25 was sent to customers. INSTRUCTIONS: 1. REVIEW lab procedures to understand how this information affects your usage 2. DISCARD affected product. 3. COMPLETE the response form provided. 4. RETURN the response form to recall@microbiologics.com 5. KEEP this letter for your records. 6. NOTIFY other facilities or customers to whom the product may have been distributed or transferred. 7. CONTACT Microbiologics if a replacement kit is needed. Microbiologics is dedicated to ensuring the success of your quality control processes. Please contact our Recall Support team at 320.229.7080 or recall@microbiologics.com with questions or concerns. Collect calls may be made.
Quantity in Commerce6 units
DistributionUS Nationwide distribution in the states of TX. UK.
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 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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