Associates of Cape Cod recalls Fungitell STAT IVD Assay for (1 3)-D-Glucan in Serum due to incorrect reconstitution instructions on clamshells. Affected units have lot # FK22008 and expire November 2023.
Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes
Associates of Cape Cod is recalling Fungitell STAT IVD Assay for (1 3)-D-Glucan in Serum because the clamshells contain incorrect reconstitution and pretreatment volume information. This could lead to inaccurate test results if users follow the wrong instructions.
The clamshells contain incorrect printed information for reconstitution and pretreatment volumes. This means users might prepare the test incorrectly, leading to inaccurate results. However, the hazard does not involve immediate physical harm.
Users of the Fungitell STAT IVD Assay for (1 3)-D-Glucan in Serum are affected, particularly those who have the specific lot number FK22008. Laboratory personnel and medical professionals using the test are most at risk.
Check for the lot number FK22008 on the package. The product expires November 2023 and has the reference number FT007. The product is sold under the brand name Fungitell STAT IVD Assay for (1 3)-D-Glucan in Serum.
Verify the lot number FK22008 and expiration date of November 2023 on the package.
The Fungitell STAT IVD Assay for (1 3)-D-Glucan in Serum with lot number FK22008 and expiration date November 2023.
The clamshells contain incorrect information for reconstitution and pretreatment volumes, which could lead to inaccurate test results.
Check the lot number and expiration date. If you have the specific lot number FK22008, contact Associates of Cape Cod for further instructions.
We’ve drafted a message you can send Associates of Cape Cod to request your refund or repair — edit it as you like.
Subject: Recall Z-1774-2022 — Associates of Cape Cod Associates of Cape Cod Hello, I own a Associates of Cape Cod that is covered by recall Z-1774-2022 from Associates of Cape Cod. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
