Quidel recalls MicroVue C1-Inhibitor Plus EIA kits with specific lot numbers for potential low OD values causing test failures. Affected kits may produce inaccurate results.
Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.
Quidel is recalling certain MicroVue C1-Inhibitor Plus EIA kits that may produce low optical density (OD) values, causing test runs to fail. This could lead to inaccurate results in measuring functional C1-inhibitor protein levels in blood tests.
The affected microtiter plates may produce low optical density values during testing, which can cause the test run to fail. This leads to inaccurate results when measuring functional C1-inhibitor protein levels in blood samples.
People using the MicroVue C1-Inhibitor Plus EIA kits with lot numbers 213783 or higher, and those who test blood samples for C1-inhibitor protein levels. Laboratory users are most at risk.
Check the lot number on the kit label; affected kits have lot number 213783 or higher. The product includes a unique identifier (UDI) starting with 30014613335580.
Look for the lot number on the kit label; affected kits have a lot number of 213783 or higher.
The affected microtiter plates may produce low optical density values, causing test runs to fail and inaccurate results.
Check the lot number on the kit label; affected kits have a lot number of 213783 or higher.
No, but you should check the lot number to ensure you have an unaffected kit.
We’ve drafted a message you can send Quidel to request your refund or repair — edit it as you like.
Subject: Recall Z-1308-2023 — Quidel Quidel Hello, I own a Quidel that is covered by recall Z-1308-2023 from Quidel. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
