Bayer Advia 1650 Chemistry System

• • Terminated Z-2014-2021 FDA Class II ·initiated 18 May 2021

  ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current default mixer failure detection setting of 2; an erroneously elevated or depressed patient result to be reported without alert on the test result

• • Terminated Z-0755-2016 FDA Class II ·initiated 7 Oct 2015 ·on shared 510(k) K990346

  Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is run, Control Definition screen assumes range defined is 2 SD, Laboratory Information System (LIS) communication/Laboratory Automation (LAS) issue, Printer Driver Resets, ISE Calibration Ranges are too conservative for Urine Sodium, Archiving and deletion may fail and Workstation services may restart.

• • Terminated Z-0183-2016 FDA Class II ·initiated 28 Aug 2015

  ISE module may produce discrepant, unflagged results for Sodium, Potassium or Chloride when the respective electrode is left unplugged after replacement, washing or maintenance activities. The calibration and 2-level QC will fail if the electrode is left unplugged. The IFU states to calibrate the ISEs after replacement and to run two levels of controls before running patient samples.

• • Terminated Z-1399-2015 FDA Class II ·initiated 11 Feb 2015

  Siemens Healthcare Diagnostics has confirmed an issue with ADVIA Chemistry XPT software version 1.0.2. The system may cause samples to remain in an Inprocess state. Test results on a sample that is held Inprocess will not transmit to the LIS. Manual intervention is necessary to complete the processing of the samples that are held Inprocess.

• • Terminated Z-0800-2014 FDA Class II ·initiated 17 Dec 2013 ·on shared 510(k) K990346

  An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits, and it is possible for the user to misinterpret or edit the result.

• • Terminated Z-0940-2014 FDA Class II ·initiated 6 Nov 2013 ·on shared 510(k) K990346

  The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC).

• 2 recalls, same reason

  • Terminated Z-0343-2014 FDA Class II ·initiated 3 Sep 2013
  • Terminated Z-0344-2014 FDA Class II ·initiated 3 Sep 2013

  Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems.

• 2 recalls, same reason

  • Terminated Z-0353-2007 FDA Unclassified (pre-2012) ·initiated 8 Sep 2006 ·on shared 510(k) K990346
  • Terminated Z-0352-2007 FDA Unclassified (pre-2012) ·initiated 8 Sep 2006 ·on shared 510(k) K990346

  Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery observed by the customer was approximately -25%. Investigation into this issue was initiated promptly following receipt of this complaint.

• • Terminated Z-0351-2007 FDA Unclassified (pre-2012) ·initiated 8 Sep 2006 ·on shared 510(k) K990346

  Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery observed by the customer was approximately -25%.

• 3 recalls, same reason

  • Terminated Z-1448-06 FDA Unclassified (pre-2012) ·initiated 17 Feb 2006
  • Terminated Z-1449-06 FDA Unclassified (pre-2012) ·initiated 17 Feb 2006
  • Terminated Z-1450-06 FDA Unclassified (pre-2012) ·initiated 17 Feb 2006

  Low QC recovery observed on carbamazepine (CARB) results immediately following a Gentamicin (GENT) assay or a Digoxin (DIG) assay. When GENT or DIG precedes CARB, the CARB test result is artificially low (as much as -25%). PHNY was determined to also exhibit a similar carryover effect on CARB. All others were found not to produce the same reagent probe-based carryover effect.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K990346 ↗

FDA Product Code

JGS

Device Class

Class II

Regulation

21 CFR Part 862.1665

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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