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Beckman Coulter Inc. recalls SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Sync
Recalled July 3, 2013 · FDA recall Z-1613-2013 · Beckman Coulter
Hazard
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. · FDA Class II
Units
3,353 units
Sold at
Worldwide Distribution - USA Nationwide and country of Canada.
Description
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.
Product
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).
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →