Company: Beckman Coulter Inc.
Date of Enforcement Report: 6/5/2013
Class ll:
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).
Recall Number Z-1400-2013
REASON
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.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea, Ca on 4/7/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
8,774 units
DISTRIBUTION
Nationwide and Internationally
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