Cobas Analytical and Supply Unit
Brand(s)
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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