FDADecember 11, 2024device

Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.

What to do

FDA enforcement status: Ongoing

Brands named

hf acquisition

UPCs

108500650078202024231226010850065007813

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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