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Health product recall

A) Reduced On-Board Stability Sample Cleaner 1 B) Reduced On-Board Stability Sample Cleaner 2

Starting date:
March 29, 2012
Posting date:
April 15, 2012
Type of communication:
Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Identification number:
RA-73305

Reason

Reduced On-Board Stability of the sample cleaner 1 and 2 Due to regent evaporation of the bottle while standing in the defined inventory area (Sampling Area) of the Cobas 8000 without being in use.

Affected products

A) Reduced On-Board Stability Sample Cleaner 1 B) Reduced On-Board Stability Sample Cleaner 2

Lot or serial number

A) All Lots B) All Lots

Model or catalog number

A) 05352991190 B) 05968828190

Companies

Manufacturer
Roche Diagnostics GMBH