Medical device recalls Moderate risk

Helena Laboratories, Corp. recalls V8 Immunodisplacement Kit REF 1803

Recall date
April 6, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1244-2022
FDA classification
Class II
Brand / firm
Helena Laboratories, Corp.
Sold / distributed
U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,

Why it was recalled

Due to microbial growth causing interference with interpretation.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

V8 Immunodisplacement Kit REF 1803

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