Associates of Cape Cod, Inc. recalls Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum R
See all recalls from Associates of Cape Cod, Inc. →Recalled Product
Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
Hazard / Issue
Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00862696000227 Lot # FK22008 and Package Control # 113041 Exp. Date: 2023-11-21
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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