Genesis

• • Terminated Z-1022-04 FDA Unclassified (pre-2012) ·initiated 3 May 2004

  Tecan software has the potential to match the patient with a different patient's test results.

• • Terminated Z-0996-04 FDA Unclassified (pre-2012) ·initiated 5 Mar 2004

  If the files are not periodically purged from the TCW computer, it may result in patient identification/sample results mismatches.

• • Terminated Z-0869-03 FDA Unclassified (pre-2012) ·initiated 27 Feb 2003

  Firmware defect. Under certain conditions a strip rack is no longer in the initial position after a motor overload of the barcode scanner PosID2.

510(k) Number

K953345 ↗

FDA Product Code

JQW

Device Class

Class I

Regulation

21 CFR Part 862.2750

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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