Associates of Cape Cod, Inc. recalls Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
- Recall date
- August 17, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1774-2022
- FDA classification
- Class II
- Brand / firm
- Associates of Cape Cod, Inc.
- Sold / distributed
- Worldwide distribution - US Nationwide distribution in the state of CA and the countries of Austria, France, Germany, India, Ireland, Italy, Spain, UK.
Why it was recalled
Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
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