Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer… — Class II medical device recall Z-1183-2018
Terminated recall by Quidel Corporation, reported 2018-04-04. The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which
| Recall number | Z-1183-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quidel Corporation, San Diego, CA, United States |
| Recall initiated | 2017-12-15 |
| Classified | 2018-03-26 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2019-10-21 |
| Quantity | 482 units |
| Reason classes | potency |
| Serial numbers | 29001731, 29002222, 29002280, 29002356, 29002389, 29002457, 29002538, 29002598, 29003275, 29003313, 29003381, 29003389, 29003530, 29003578, 29003584, 29003607, 29003617, 29003635, 29003636, 29003675, 29003688, 29003700, 29003703, 29003731, 29003738 and 457 more |
| Model numbers | 20299 |
Product
Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.
Reason for 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1183-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.