—#130155

Product

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.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Lot Numbers: 459356 Exp. Date: November 2014; 443105 Exp. Date: November 2014

Why it was recalled

Stability of the ADVIA Centaur Cleaning Solution is not assured

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

Siemens issued an Urgent Medical Device Recall (UMDR) to customers in the US on September 12, 2014. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on September 12, 2014. These notices inform the customer of the degradation of hypochlorite in these lots of cleaning solution. Customers were instructed to discontinue use of the affected lots and dispose of the product according to local regulations or procedures. The notices should be reviewed with the facility's laboratory or medical director. Fax-back forms will be used to confirm that the customers received the UMDR. For those customers that do not return a fax-back form, a Siemens representative will follow up with those customers to ensure they received the Urgent Medical Device Recall For questions regarding this recall call 508-668-5000.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Canada. Grerat Britain, Saudi Arabia, Nepal, and Viet Nam.

Timeline

Recall initiated: 2014-09-12
Posted by FDA: 2014-11-14
Terminated: 2015-07-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130155. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.