Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
Reported: February 19, 2025 Initiated: January 20, 2025 #Z-1164-2025
Product Description
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
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.
Details
- Recalling Firm
- Microbiologics Inc
- Units Affected
- 27 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.
- Location
- Saint Cloud, MN
Frequently Asked Questions
What product was recalled? ▼
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test. Recalled by Microbiologics Inc. Units affected: 27 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 19, 2025. Severity: Moderate. Recall number: Z-1164-2025.
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