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.
FDA Recall Z-1432-2012 · Posted 2012-04-16
Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJIF
Date Initiated2009-03-26
Date Terminated2012-04-18
Product Quantity3,388 kits
Reason for Recall
The Ammonia Reagent lot M808278 may fail calibration or cause a low shift in Quality Control recovery on some SYNCHRON Systems.
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.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the country of Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.