# K922072: Kodak Ektachem 250 Analyer

- Pathway: 510(k) (Traditional)
- Applicant: Eastman Kodak Company
- Decided: Jul 10, 1992 after 67 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K023875: Vitros Chemistry Products Alb Slide, Vitros Chemistry Products Calibrator Kit 4 (2002), 1 descendant of its own
- K191316: VITROS XT Chemistry Products ALB-TP Slides (2019), 0 descendants of its own
- K091975: Integrated Laboratory Automation Solution (2010), 0 descendants of its own

## Recalls of this device
- Jul 8, 2019 · Class II · Z-2176-2019: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- Jul 8, 2019 · Class II · Z-2174-2019: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- Jul 8, 2019 · Class II · Z-2175-2019: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- Jul 8, 2019 · Class II · Z-2177-2019: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- Apr 8, 2019 · Class II · Z-1933-2019: Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
- Apr 8, 2019 · Class II · Z-1934-2019: Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
- Apr 8, 2019 · Class II · Z-1936-2019: Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
- Apr 8, 2019 · Class II · Z-1935-2019: Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
- Dec 21, 2015 · Class II · Z-1071-2016: 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 f
- Dec 21, 2015 · Class II · Z-1072-2016: 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 f
- Jan 9, 2014 · Class II · Z-1226-2014: 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 result
- Oct 17, 2013 · Class II · Z-1088-2014: Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.
- Jun 12, 2013 · Class II · Z-0296-2014: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
- Jun 12, 2013 · Class II · Z-0305-2014: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
- Feb 2, 2012 · Not classified · Z-1277-2012: 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 Calibratio

Source page: https://510kreport.com/device/K922072
Methodology: https://510kreport.com/methodology