Z-1432-2012

SYNCHRON Ammonia (AMM) Reagent

Name: Z-1432-2012 SYNCHRON Ammonia (AMM) Reagent
Creator: Beckman Coulter Inc.
Published: 2009-03-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2009-03-26 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of SYNCHRON Ammonia (AMM) Reagent Product Usage: AMM reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON... on 2009-03-26. The reason FDA records is "The Ammonia Reagent lot M808278 may fail calibration or cause a low shift in Quality Control recovery on some SYNCHRON Systems". 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-1432-2012
Status: Terminated
Initiated: 2009-03-26
Posted: 2012-04-16
Terminated: 2012-04-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: SYNCHRON Ammonia (AMM) Reagent Product Usage: AMM reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Ammonia Calibrators, is intended for the quantitative determination of Ammonia concentration in human plasma.
Product code: JIF Enzymatic Method, Ammonia
Reason for recall: The Ammonia Reagent lot M808278 may fail calibration or cause a low shift in Quality Control recovery on some SYNCHRON Systems.
Root cause tag: manufacturing process
FDA root cause: Unknown/Undetermined by firm
Action: Beckman Coulter mailed a Product Corrective Action (PCA) Letter on April 13, 2009 dated April 10, 2009 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers to discontinue use and discard appropriately the lot number(s) of the affected product and contact their Customer Service Representative at (800) 526-3821 (US), or (800)463-7828 for reagent replacement. Customers were instructed to complete and return the enclosed response form within 10 days so that Beckman Coulter may maintain records. Customers were told to call the Customer Support Center (Hotline) at (800) 854-3633 with any questions regarding the PCA letter.
Quantity in commerce: 3,388 kits
Distribution: Worldwide Distribution - USA (nationwide) and the country of Canada
Product codes and lots: Lot Number M808278

Product code JIF

K984402Class ISynchron Systems Ammonia (Amm) ReagentBeckman Coulter, Inc. / cleared 1999-01-29

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)