PlainRecalls
FDA Devices Low Class III Terminated

ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments.

Reported: November 26, 2014 Initiated: September 12, 2014 #Z-0214-2015

Product Description

ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments.

Reason for Recall

Stability of the ADVIA Centaur Cleaning Solution is not assured

Details

Units Affected
4645 (12 pk)
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Canada. Grerat Britain, Saudi Arabia, Nepal, and Viet Nam.
Location
East Walpole, MA

Frequently Asked Questions

What product was recalled? ▼
ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments.. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 4645 (12 pk).
Why was this product recalled? ▼
Stability of the ADVIA Centaur Cleaning Solution is not assured
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 26, 2014. Severity: Low. Recall number: Z-0214-2015.

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