ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP

FDA device recall Z-0229-2015 · posted 2014-11-19 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc

Reason for recall

Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur Systems BNP reagent contains an ADVIA Centaur Systems FT4 human-readable side label.

Action taken

A Customer Notification (CN) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on October 03, 2014 to be delivered to customers on October 06, 2014 via Federal Express. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on October 06, 2014. These notices inform the customer of the potential to receive an ADVIA Centaur BNP ReadyPack with a FT4 human-readable side label. Siemens instructs customers to inspect their inventory and discard any BNP Readypacks with a FT4 side label. In addition, Siemens informs customers the end labels of the affected ReadyPacks correctly identify the pack as BNP and Siemens has confirmed the reagent within these packs is BNP Reagent. Therefore valid BNP results will be generated when calibrating and running quality control or patient samples. Fax-back forms will be used to confirm that the customers received the notification. 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 Customer Notification and completed the required actions.

Root cause

Labeling mix-ups

Status

Terminated

Product code

NBC

Quantity affected

100 test - 4,600 kits; 500 test - 1,878 kits

Distribution

Worldwide Distribution - US Nationwide including Puerto Rico; and countries of: Canada, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Fren.Polynesia, Germany, Great Britain, Gre

Date initiated

2014-10-06

Date posted

2014-11-19

Date terminated

2015-07-22

Location

East Walpole, MA

Related 510(k) clearances