Recall Z-1163-2025
Microbiologics Inc · initiated January 20, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
Codes / lots: UDI/DI 70845357043077, Lot Number 8234-22
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: Under Investigation by firm
Action taken
Microbiologics 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.
Details
- Recall number
- Z-1163-2025
- Initiated
- January 20, 2025
- Posted by FDA
- February 12, 2025
- Product code
- OHQ – Multi-Analyte Controls Unassayed
- Quantity
- 16 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1164-2025 Class II | Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated…Internal quality control procedures were not followed correctly for the testing/release of three lots of… | 01/20/2025Open, Classified |