Cobas H 232 Instruments (2019-10-22)

Starting date:

October 22, 2019

Posting date:

January 6, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71973

Last updated: 2020-01-07

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  Reason
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  Affected products

Affected Products

Cobas H 232 Instruments

Reason

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.

 

Affected products