Reported Apr 4, 2018 · Terminated
Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based…
Quidel Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Quidel Corporation · 10165 McKellar Ct · San Diego, CA · 92121-4201
Is this the product you have?
- 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.
- Lot codes and dates
- Serial Numbers
482 of 482 codes
290039562900402529004086290040722900418829004150290042292900412729004232290042042900425629004362290041552900429029004329290043472900435029004353290043702900439029004396290044152900338129003814290041832900425929004263290042812900431729004343290042052900420929004001290040622900407729003915290040362900405729003979290040852900414429004267290043222900396029003991290041632900419029004330290039922900403329003987290043062900432529004332290040662900433529004373290044302900422329004299
- Serial Numbers
- Amount recalled
- 482 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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