Product Wiki · Recalls · Health Canada — Medical Devices

COBAS S201 System Pooling and Data Management (PDM) V3.0.35… — recall 53153

Health Canada — Medical Devices · Canada · 2015-05-21 · Type III

As described by Health Canada — Medical Devices: COBAS S201 System Pooling and Data Management (PDM) V3.0.35 (2015-04-20)

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
53153
Date of alert
2015-05-21
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: The pooling software can create pools containing more or less donors than originally intended during simultaneous pooling runs for both the Cobas TaqScreen MPX and Cobas TaqScreen WNV tests, when the donor tube carrier on the Hamilton STAR/STARlet pipettor is missing a donor tube in any position within the donor tube carrier.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cobas-s201-system-pooling-and-

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