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:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Health products - Medical devices - 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

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