Device 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).
Z-1613-2013
Product summary
- Event
- Event 65377
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,353 units
- Official record key
device-enforcement:Z-1613-2013
Official wording
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.
Code information: Part Number A95550, Lot Number M210077
Distribution pattern: Worldwide Distribution - USA Nationwide and country of Canada.
Derived failure modes
-
Unknown
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.