Phadia recalls specific lots of ImmunoCAP Allergen c6 for stability issues that could affect allergy test accuracy. Affected units include lots 991DA through 991D9 with expiration dates up to April 2018.
The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.
Phadia is recalling certain lots of ImmunoCAP Allergen c6 allergy test kits because they may not be stable as intended. This could lead to inaccurate allergy test results if used in the lab. The recall affects specific production lots with expiration dates up to April 2018.
The test kits may not maintain stability properly, which could cause inaccurate allergy test results. This means the test might not correctly measure allergen-specific IgE levels in patient samples.
Lab users who have the specific lots of ImmunoCAP Allergen c6 with expiration dates up to April 2018 are affected. Healthcare providers and allergy testing facilities using these kits are most at risk.
Check the product lot number on the ImmunoCAP Allergen c6 kit. Affected lots include 991DA (exp. 2018.04.30), 991DC (exp. 2018.07.31), 991D7, and 991D9 (exp. 2018.02.28).
Look for the lot number on the ImmunoCAP Allergen c6 kit to determine if it is affected.
Phadia ImmunoCAP Allergen c6, Amoxicilloyl kits with lot numbers 991DA through 991D9 and expiration dates up to April 2018.
The stability specifications for these kits were not met, which could lead to inaccurate allergy test results.
Check the lot number on the kit; affected lots include 991DA (exp. 2018.04.30), 991DC (exp. 2018.07.31), 991D7, and 991D9 (exp. 2018.02.28).
We’ve drafted a message you can send Phadia to request your refund or repair — edit it as you like.
Subject: Recall Z-1313-2018 — Phadia Phadia Hello, I own a Phadia that is covered by recall Z-1313-2018 from Phadia. 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.