—#128153

Product

Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219 SMN: 10310026 Intended Use: In vitro diagnostic use. Acid Regent is a component of the ADVIA Centaur and ADVIA Centaur XP instruments

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Kit Lot Number: 454779 Exp. Date: 28 February, 2015

Why it was recalled

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

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

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.

Recalling firm

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

Distribution

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

Timeline

Recall initiated: 2014-06-02
Posted by FDA: 2014-06-26
Terminated: 2015-02-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128153. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.