Product Wiki · Recalls · Health Canada — Medical Devices

Cobas H 232 Instruments (2019-10-22) — recall 63010

Health Canada — Medical Devices · Canada · 2020-01-06 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
63010
Date of alert
2020-01-06
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Potential defect with the cardiac pipettes used with the cobas H 232 system. Please be advised that this urgent medical device correction (Roche ref. No. rr201929) is not a product removal, as the product itself can still be used as long as users follow the instruction provided in the warning stated in the action taken by Roche diagnostics. In the past months Roche have received 9 customer complaints worldwide for cardiac pipettes (out of more than 11 million distributed single syringes). The following issues were observed: 8 cases where the needle came off the pipette and 1 case where the needle became stuck in a sample tube. The manufacturer has carried out an investigation and confirmed these findings. In all related complaints the issue was detected by the user and no injury occurred.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cobas-h-232-instruments-2019-1

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