Recall Z-1400-2013
Beckman Coulter Inc. · initiated April 17, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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).
Codes / lots: Lot Number: M206209
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1400-2013
- Initiated
- April 17, 2013
- Posted by FDA
- May 24, 2013
- Terminated
- October 22, 2014
- Product code
- KHP – Acid, Lactic, Enzymatic Method
- 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, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab…
- Recalling firm
- Beckman Coulter Inc., Brea, CA