ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP Cleaning Solution (For in vitro diagnostic use with the ADVIA Ce

FDA device recall Z-0214-2015 · posted 2014-11-14 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc

Reason for recall

Stability of the ADVIA Centaur Cleaning Solution is not assured

Action taken

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.

Root cause

Material/Component Contamination

Status

Terminated

Product code

JJE

Quantity affected

4645 (12 pk)

Distribution

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

Date initiated

2014-09-12

Date posted

2014-11-14

Date terminated

2015-07-17

Location

East Walpole, MA