Phadia recalls ImmunoCAP Allergen c5 Ampicilloyl (article 14-4450-01) due to stability problems. This affects specific IgE test kits with lot numbers 990DS through 990DY.
The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
Phadia is recalling ImmunoCAP Allergen c5 Ampicilloyl test kits because they may not meet stability requirements. This could lead to inaccurate allergy test results if used after the expiration date.
The test kits may not meet stability specifications, meaning they could become inaccurate after the expiration date. This could lead to incorrect allergy test results if used beyond their expiration dates.
People who own or use ImmunoCAP Allergen c5 Ampicilloyl test kits with lot numbers 990DS through 990DY are affected. Those using these kits for allergy testing are most at risk of inaccurate results.
Check the lot number on the test kit, which is listed as 990DS, 990DT, 990DW, 990DX, or 990DY. These kits were sold with expiration dates up to December 31, 2017, through May 31, 2018.
Look for the lot number on the test kit to confirm it is one of 990DS, 990DT, 990DW, 990DX, or 990DY.
The stability specifications of ImmunoCAP Allergen c5 Ampicilloyl were not met, which could lead to inaccurate allergy test results.
The expiration dates vary by lot number: 990DS expires December 31, 2017; 990DT expires January 31, 2018; 990DW expires March 31, 2018; 990DX expires May 31, 2018; and 990DY has an unspecified expiration date.
Check the lot number on the test kit. If it is 990DS, 990DT, 990DW, 990DX, or 990DY, it is part of this recall.
We’ve drafted a message you can send Phadia to request your refund or repair — edit it as you like.
Subject: Recall Z-1312-2018 — Phadia Phadia Hello, I own a Phadia that is covered by recall Z-1312-2018 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.
