—#84542

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.

FDA product code: JIF — Enzymatic Method, Ammonia
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K984402
Affected lot / code info: Lot Number M808278

Why it was recalled

The Ammonia Reagent lot M808278 may fail calibration or cause a low shift in Quality Control recovery on some SYNCHRON Systems.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and the country of Canada

Timeline

Recall initiated: 2009-03-26
Posted by FDA: 2012-04-16
Terminated: 2012-04-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #84542. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.