Beckman Coulter Inc.: Medical Device Recall in 2013 - (Recall #: Z-1400-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class II

Date Initiated: April 17, 2013

Date Posted: June 5, 2013

Recall Number: Z-1400-2013

Event ID: 63367

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.

Status: Terminated

Product Quantity: 8,774 units

Code Information:

Lot Number: M206209

Distribution Pattern:

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 Emirates, United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated