Health product recall

EMIT® 2000 Quinidine Assay

Last updated

Summary

Product
EMIT® 2000 Quinidine Assay
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.  

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

EMIT® 2000 Quinidine Assay

2597

OSR4Q229

EMIT® 2000 Quinidine Assay

2709

OSR4Q229

EMIT® 2000 Quinidine Assay

2627

OSR4Q229

Issue

Siemens Healthineers has confirmed through the investigation of customer complaints and internal investigation that the potential for Repeatability precision to be greater than 10% coefficient of variation (CV) and Within-Lab precision to be greater than 15% CV. Using a 20 - day ANOVA study, Repeatability ranged from 3.09% to 52.03% CV across the assay range when using multiple lots of reagents on the DXC 700 AU and the Viva-ProE. In the same study, Within-Lab precision ranged from 7.72% to 53.39% CV across the assay range.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Siemens Healthcare Diagnostics Inc.

500 Gbc Drive, Newark, Delaware, United States, 19714

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82788

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