Recall Z-1400-2013 ยท KHP Acid, Lactic, Enzymatic Method
Beckman Coulter Inc.
Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).
| Date | May 24, 2013 (initiated Apr 17, 2013) |
| Status | Terminated |
| Reason | Beckman Coulter initiated the recall for the Lactate Assay (LACT) Lot M206209 as they received a customer complaint of error message (RXN RATE HI), i.e. no numerical values reported for samples containing Lactate concentration greater than 6.5 mmol/L. |
| Root cause | Under Investigation by firm |
| Action | Beckman Coulter sent an Urgent Product Correction letter dated April 17, 2013 to all affected customers. The letter identified the affected product, problem actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Beckman Coulter Customer Support Center (Call Center) on the Beckman Website at http://www.beckmancoulter.com/customersupport/support/ or call (800) 854-3633 in the US and Canada. |
| Quantity | 8,774 units |
| Distribution | Worldwide Distribution - USA Nationwide and the countries of Canada, Australia, Belgium, Czech Republic, France, French Polynesia, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Jordon, Kuwait, Lebanon, Malawi, Morocco, Namibia, Netherlands, oman, Panama, Paraguay, Qatar, Reunion, Singapore, Slo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.