Recall Z-1432-2012 ยท JIF Enzymatic Method, Ammonia
Beckman Coulter Inc.
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.
| Date | Apr 16, 2012 (initiated Mar 26, 2009) |
| Status | Terminated |
| Reason | The Ammonia Reagent lot M808278 may fail calibration or cause a low shift in Quality Control recovery on some SYNCHRON Systems. |
| 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 |
| Quantity | 3,388 kits |
| Distribution | Worldwide Distribution - USA (nationwide) and the country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984402 | SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT Beckman Coulter, Inc., Jan 29, 1999 |