Lipase Flex Reagent Cartridge

• 2 recalls, same reason

  • Terminated Z-0466-2019 FDA Class II ·initiated 7 Sep 2018
  • Terminated Z-0465-2019 FDA Class II ·initiated 7 Sep 2018

  There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.

• • Terminated Z-0588-2011 FDA Unclassified (pre-2012) ·initiated 10 Mar 2010

  Open Well instability: After calibration, QC shifts high (out of range) after the Flex Well is hydrated. Shifts of up to 20% have been observed in both QC and patient samplesas soon as two hours post hydration.

510(k) Number

K952816 ↗

FDA Product Code

CHI

Device Class

Class I

Regulation

21 CFR Part 862.1465

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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