Kodak Extachem Clinical Chemistry Slide Digoxin (Dgxn)

• 2 recalls, same reason

  • Ongoing Z-0902-2025 FDA Class II ·initiated 5 Dec 2024
  • Ongoing Z-0901-2025 FDA Class II ·initiated 5 Dec 2024

  Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.

• • Terminated Z-0310-2014 FDA Class II ·initiated 12 Jun 2013

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

• • Terminated Z-2211-2012 FDA Class II ·initiated 28 Jun 2012

  Ortho Clinical Diagnostics revised the VITROS Chemistry Products DGXN Slides Instructions for Use (IFU) and removed heparin plasma as a recommended specimen type for VITROS DGXN Slides

510(k) Number

K942610 ↗

FDA Product Code

LFM

Device Class

Class II

Regulation

21 CFR Part 862.3300

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Kodak Surecell Hcg Urine Test, Modification

  Class II

  FDA 510(k) K936287 Active Cleared 8 Apr 1994

• Kodak Ektaspeed Dental X-Ray Film

  Class I

  FDA 510(k) K800901 Active Cleared 20 May 1980

• Kodak X-Omat 3000 Ra Processor

  Class II

  FDA 510(k) K951396 Active Cleared 15 May 1995

• Kodak X-Omat M43A, M43, & Clinic 1 Processors

  Class II

  FDA 510(k) K934350 Active Cleared 21 Mar 1994

• Amerlite Prolactin-30 Assay

  Class I

  FDA 510(k) K922170 Active Cleared 2 Sep 1992

• Trophypan C with Orthoimaging/Omsimaging Accessory

  Class II

  FDA 510(k) K040556 Active Cleared 7 Apr 2004

See all devices from Eastman Kodak Company →