Beckman Coulter Inc.: Medical Device Recall in 2013 - (Recall #: Z-1613-2013)

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 System(s) Lactate (LACT) Reagent. 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: May 28, 2013

Date Posted: July 3, 2013

Recall Number: Z-1613-2013

Event ID: 65377

Reason for Recall:

Beckman Coulter has confirmed customer reports of LACT Lot M210077 failing calibration with error condition OCR LOW. The calibration failures appear to be related to improper shipping or storage conditions (frozen reagent). Failed calibration of LACT may cause a delay in reporting results.

Status: Terminated

Product Quantity: 3,353 units

Code Information:

Part Number A95550, Lot Number M210077

Distribution Pattern:

Worldwide Distribution - USA Nationwide and country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated