Kodak Ektachem 250 Analyer

• 4 recalls, same reason

  • Terminated Z-2174-2019 FDA Class II ·initiated 8 Jul 2019
  • Terminated Z-2176-2019 FDA Class II ·initiated 8 Jul 2019
  • Terminated Z-2175-2019 FDA Class II ·initiated 8 Jul 2019
  • Terminated Z-2177-2019 FDA Class II ·initiated 8 Jul 2019

  Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

• 4 recalls, same reason

  • Terminated Z-1935-2019 FDA Class II ·initiated 8 Apr 2019
  • Terminated Z-1936-2019 FDA Class II ·initiated 8 Apr 2019
  • Terminated Z-1933-2019 FDA Class II ·initiated 8 Apr 2019
  • Terminated Z-1934-2019 FDA Class II ·initiated 8 Apr 2019

  Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

• 2 recalls, same reason

  • Terminated Z-1072-2016 FDA Class II ·initiated 21 Dec 2015
  • Terminated Z-1071-2016 FDA Class II ·initiated 21 Dec 2015

  Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).

• • Terminated Z-1226-2014 FDA Class II ·initiated 9 Jan 2014 ·on shared 510(k) K922072

  An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to obtain and report TBIL, Bu, Bc, and derived tests results. The correct assay value is 0.8658.

• • Terminated Z-1088-2014 FDA Class II ·initiated 17 Oct 2013 ·on shared 510(k) K922072

  Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.

• 2 recalls, same reason

  • Terminated Z-0296-2014 FDA Class II ·initiated 12 Jun 2013 ·on shared 510(k) K922072
  • Terminated Z-0305-2014 FDA Class II ·initiated 12 Jun 2013 ·on shared 510(k) K922072

  Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

• • Terminated Z-1277-2012 FDA Not yet classified ·initiated 2 Feb 2012 ·on shared 510(k) K922072

  Ortho Clinical Diagnostics received complaints of lower than expected results (< 6 U/L) for samples that were known to be outside of the measuring (reportable) range (> 1000 U/L) when using Calibration Diskette/Assay Data Diskette Data Release Version (DRV) 5653 through 5666 and VITROS Chemistry Products ALT Slides, Generation (GEN) 26 (Product Code 1655281).

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

510(k) Number

K922072 ↗

FDA Product Code

JJE

Device Class

Class I

Regulation

21 CFR Part 862.2160

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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