Reported Sep 28, 2022 · Terminated

Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007

Associates of Cape Cod, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Associates of Cape Cod, Inc. · 124 Bernard E Saint Jean Drive · East Falmouth, MA · 02536-4445

Is this the product you have?

  • Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan
  • in Serum RefFT007
Lot codes and dates
  • UDI-DI00862696000227 Lot # FK22008 and Package Control # 113041 Exp
  • Date2023-11-21
Amount recalled
243 kits

Where it was sold

  • Nationwide
  • CA

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 12, 2024 · Data as of Sep 19, 6:18 PM UTC

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