Recall Z-1400-2013— Beckman Coulter Inc.
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2013-04-17, terminated 2014-10-22. FDA's recall record names no specific 510(k) clearance for this event. 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).. 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
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-17
- Terminated
- 2014-10-22
- Firm location
- Brea, CA, United States
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).
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.