Recall Z-1613-2013— Beckman Coulter Inc.
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2013-05-28, terminated 2014-06-03. FDA's recall record names no specific 510(k) clearance for this event. 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).. Reason: 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..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-28
- Terminated
- 2014-06-03
- Firm location
- Brea, CA, United States
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).
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.
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