Abx Pentra 60C+ Hematology Analyzer

• • Terminated Z-1149-03 FDA Unclassified (pre-2012) ·initiated 4 Jun 2003

  Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door.

• • Terminated Z-0570-03 FDA Unclassified (pre-2012) ·initiated 20 Jan 2003 ·on shared 510(k) K003677

  Failure to cycle properly ammong samples.

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

510(k) Number

K003677 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Abx Micros 60 Hematology Analyzer

  Class II

  FDA 510(k) K014203 Active Cleared 28 Feb 2002

• Modification to Pentra 60 and Pentra 60C+

  Class II

  FDA 510(k) K030144 Active Cleared 31 Jan 2003

• Pentra 80

  Class II

  FDA 510(k) K024002 Active Cleared 3 Jan 2003

• Abx Micros Crp

  Class II

  FDA 510(k) K002646 Active Cleared 26 Oct 2000

• Abx Pentra 120 Retic Automated Hematology Analyzer

  Class II

  FDA 510(k) K991839 Active Cleared 11 Aug 1999

• ABX Pentra 60 Hematology Analyzer

  Class II

  FDA 510(k) K992511 Active Cleared 15 Oct 1999

See all devices from Abx Diagnostics →