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Recall Observatory FDA recall evidence

Device product

Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test

Z-1164-2025

January 20, 2025

Class II

Product summary

Firm
Microbiologics Inc
Event
Event 96166
Status
Ongoing
Classification
Class II
Quantity
27 units
Official record key
device-enforcement:Z-1164-2025

Official wording

Reason: 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.

Code information: UDI/DI 70845357043077, Lot Numbers: 8235-32, 8235-33

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.