medical Class II Updated 2025-02-19

Microbiologics Inc recalls Microbiologics Multi-Strain Human Papillomavirus (HPV) Contr

Recalled Product

Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI/DI 70845357043077, Lot Number 8234-22
View official government recall

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