Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT

FDA device recall Z-1400-2013 · posted 2013-05-24 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

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.

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

KHP

Quantity affected

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, Le

Date initiated

2013-04-17

Date posted

2013-05-24

Date terminated

2014-10-22

Location

Brea, CA