Quidel recalls Sofia 2 Analyzer (Catalog 20299) with serial numbers listed. The device may have calibration errors that cause test failures, especially near assay cutoffs.
The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which may lead to a failure when calibration is first performed. There may also be e remote possibility that incorrect qualitative test results for patient samples near the assay cutoff may be reported.
Quidel is recalling specific models of Sofia 2 Analyzers (Catalog Number 20299) due to calibration errors that could cause inaccurate test results. This affects laboratory use and may lead to incorrect patient test outcomes near the assay cutoff.
The calibration was incorrectly set during manufacturing, which may cause the analyzer to fail during its first test. There's also a remote possibility of incorrect results for patient samples near the assay cutoff.
Laboratory professionals and healthcare facilities using the Sofia 2 Analyzer with the listed serial numbers. Users most at risk are those performing tests where precise results are critical, such as in clinical settings.
Check if your Sofia 2 Analyzer has the Catalog Number 20299 and one of the listed serial numbers (29003956, 29004025, and other numbers provided in the recall).
Verify your device's serial number against the list of affected units provided in the recall notice.
The calibration for the affected batch was incorrectly set during manufacturing, which may lead to test failures when calibration is first performed.
The recall states there is a remote possibility of incorrect qualitative test results near the assay cutoff, but no mention of serious injury or death.
Check if your Sofia 2 Analyzer has Catalog Number 20299 and one of the listed serial numbers (29003956, 29004025, and other numbers provided in the recall).
We’ve drafted a message you can send Quidel to request your refund or repair — edit it as you like.
Subject: Recall Z-1183-2018 — Quidel Quidel Hello, I own a Quidel that is covered by recall Z-1183-2018 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.
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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.
