SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantita

FDA device recall Z-2149-2014 · posted 2015-06-26 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc

Reason for recall

Complaints of failed calibration.

Action taken

Siemens sent an Urgent Medical Device Correction (UMDC) letter to all affected Siemens Healthcare Diagnostics customers in the United States on June 23, 2014 via Federal Express. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on June 23, 2014 via hard copy, email, and/or fax per each country's local regulations. These notices inform the customer of the potential for low calibrator deviation failures when using ADVIA Centaur Systems BNP kit lots ending in 172 on the ADVIA Centaur CP due to an error on the master curve card. Siemens informs customers if a successful calibration is achieved, the results obtained are valid. If customers are unable to obtain a successful calibration on the ADVIA Centaur CP, they should switch to an alternative lot of BNP assay. 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 UMDC. 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 Correction and completed the required actions. Customers with questions were instructed to contact their Siemens Customer Care Center or their local Siemens technical support representative. For questions regarding this recall call 877-229-3711.

Root cause

Other

Status

Terminated

Product code

NBC

Quantity affected

1,191 kits

Distribution

Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada, Albania, Argentina, Australia, Bosnia Herzeg., Brazil, Chile, Colombia, Egypt, Georgia, Hong Kong, India,

Date initiated

2014-06-23

Date posted

2015-06-26

Date terminated

2016-03-31

Location

East Walpole, MA

Related 510(k) clearances