Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778

FDA device recall Z-1927-2014 · posted 2014-06-26 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc

Reason for recall

Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles

Action taken

Siemens Healthcare Diagnostics issued Urgent Medical Device Recall (UMDR) to customers in the United States on June 02, 2014 and a Urgent Field Safety Notice (UFSN) issued outside the United States on June 02, 2014. These notices inform the customer of the potential for swollen acid bottles due to confirmed metal contamination. Customers with alternative lots in inventory were instructed to transition to the alternative lot upon receipt of the communication. Customers without an alternative lot of acid in inventory were informed that Siemens proactively shipped an alternative lot to their laboratory and they should transition to that lot upon its receipt. Siemens also informed customers without an alternative lot that they may continue to run and report patient results using the affected lot of acid. Questions contact your Siemens Customer Care Center or your local Siemens technical support representative.

Root cause

Material/Component Contamination

Status

Terminated

Product code

JJE

Quantity affected

3,839 kits

Distribution

Worldwide Distribution - US Nationwide and the countries of Canada, Argentina, China, Colombia, Korea, Malyasia, New Zealand, Mexico, Guatemala, and Singapore.

Date initiated

2014-06-02

Date posted

2014-06-26

Date terminated

2015-02-05

Location

East Walpole, MA