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Terminated

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.

FDA Recall Z-1183-2018 · Posted None

Recalling FirmQuidel Corporation
Recall StatusTerminated
Product CodePSZ
Date Initiated2017-12-15
Date Terminated2019-10-21
Product Quantity482 units

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.

Firm Action

Quidel sent and Urgent Product Recall letter dated December 15, 2017. The letter instructs the user to discontinue use of the device until new firmware can be installed. For further questions, please call (800) 874-1517.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

US Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162438Sofia Influenza A+B FIA on Sofia 2Quidel Corporation · 2017-04-14K162911Sofia RSV FIA on Sofia 2 analyzerQuidel Corporation · 2017-02-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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