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U.S. Department of Health and Human Services

Class 2 Device Recall MultiStrain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet)

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 Class 2 Device Recall MultiStrain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet)see related information
Date Initiated by FirmJanuary 20, 2025
Date PostedFebruary 12, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1164-2025
Recall Event ID 96166
Product Classification Multi-analyte controls unassayed - Product Code OHQ
ProductMicrobiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
Code Information UDI/DI 70845357043077, Lot Numbers: 8235-32, 8235-33
FEI Number 2150138
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		Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.
FDA Determined
Cause 2		Under Investigation by firm
ActionMicrobiologics issued and Urgent Medical Device Recall notice to its consignees on 01/20/2025 via email. The notice explained the issue and requested the following actions be taken: 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. Please contact our Recall Support team at 320.229.7080 or recall@microbiologics.com with questions or concerns.
Quantity in Commerce27 units
DistributionWorldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.
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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