أجهزة طبية
EMIT® 2000 Quinidine Assay
Summary
| Type | Health product recall |
|---|---|
| Product | EMIT® 2000 Quinidine Assay |
| Issue | Medical devices - Performance |
| What to do | Contact the manufacturer if you require additional information. |
| Audience | Healthcare |
| Brand(s) | Siemens Healthcare Diagnostics Inc. |
| Last updated | 2026-10-15 |
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.
Details
| Original published date | 2026-10-15 |
|---|---|
| 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 | 2026-09-21 |
| Identification number | RA-82788 |
Source: Government of Canada, Recalls and safety alerts – https://recalls-rappels.canada.ca/en/alert-recall/emitr-2000-quinidine-assay