Z-1927-2014Class II

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

Name: Z-1927-2014 Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2014-06-02
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-06-02 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219 SMN... on 2014-06-02. FDA classified it as Class II and gives the reason as "Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1927-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-02
Posted: 2014-06-26
Terminated: 2015-02-05
Recalling firm: Siemens Healthcare Diagnostics Inc.
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
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: 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.
Quantity in commerce: 3,839 kits
Distribution: Worldwide Distribution - US Nationwide and the countries of Canada, Argentina, China, Colombia, Korea, Malyasia, New Zealand, Mexico, Guatemala, and Singapore.
Product codes and lots: Kit Lot Number: 454779 Exp. Date: 28 February, 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1927-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1927-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-26

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)