Recall Z-1183-2018— Quidel Corporation
Class II · Terminated
Class II FDA medical device recall by Quidel Corporation, initiated 2017-12-15, terminated 2019-10-21. It names 2 FDA 510(k) clearances: K162438, K162911. 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: 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..
- Recalling firm
- Quidel Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-15
- Terminated
- 2019-10-21
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.