Recall Monitor
Health Products

EMIT® 2000 Quinidine Assay

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: EMIT® 2000 Quinidine Assay
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
EMIT® 2000 Quinidine Assay2597OSR4Q229
EMIT® 2000 Quinidine Assay2709OSR4Q229
EMIT® 2000 Quinidine Assay2627OSR4Q229

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.

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