Health product recall

Cobas Analytical and Supply Unit

Last updated

Summary

Product
Cobas Analytical and Supply Unit
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare
Industry

Affected products

Affected products

Lot or serial number

Model or catalogue number

Cobas E 402 Analytical Unit

2131-08
2112-03
2131-05
2144-10

09031553001

Cobas 8000 E 801

More than 10 numbers, contact manufacturer.

07682913001

Cobas E 801 Analytical Unit

More than 10 numbers, contact manufacturer.

08454345001

Cobas 8000 Core Unit

More than 10 numbers, contact manufacturer.

05641446001

Cobas Pure Sample Supply Unit

2142-01
2114-04
2146-07
2141-08

09031537001

Cobas Pro Sample Supply Unit

More than 10 numbers, contact manufacturer.

08464502001
09205632001

Issue

Manufacturer internally detected a potential operational software issue affecting Cobas Pure E 402, Cobas Pro and/or Cobas 8000 E 801 instruments. The issue may occur under specific instrument conditions and sequence of laboratory actions when the quick start mode is activated on the instrument.

Recall start date: July 18, 2022

Additional information

Details
Original published date: 2022-08-22
Alert / recall type
Health product recall
Category
Health product - Medical device - Chemistry
Health product - Medical device - General hospital and personal use
Companies

Roche Diagnostics Gmbh

Sandhoferstrasse 116, Mannheim, Germany, 68305

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-64467