Quidel Sofia 2 Analyzer Recall: Calibration Error May Cause Test Failures
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.
Lower-risk recall
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/72315-quidel-sofia-2-analyzer-recall-calibration-error-may-cause-test.
Source Summary by GovInfoNow · govinfonow.com/recall/72315-quidel-sofia-2-analyzer-recall-calibration-error-may-cause-test · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1183-2018
Cite this page
“Quidel Sofia 2 Analyzer Recall: Calibration Error May Cause Test Failures.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/72315-quidel-sofia-2-analyzer-recall-calibration-error-may-cause-test. Based on FDA recall #Z-1183-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1183-2018%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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).
- Brand
Quidel- Category
Medical device
What to do — step by step
Check Serial Number
Verify your device's serial number against the list of affected units provided in the recall notice.
How this recall unfolded
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1183-2018 (December 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1183-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.