FDA-Device2022-06-15Class II

V8 Immunodisplacement Kit REF 1803

Helena Laboratories, Corp.
Hazard

Due to microbial growth causing interference with interpretation.

Sold states
U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,
Affected count
51 kits
Manufactured in
1530 Lindbergh Dr, Beaumont, TX, United States
Products
V8 Immunodisplacement Kit REF 1803

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1244-2022

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