Roche Unimate 3/Unimate 5 HBA1C, HBA1C Calibrator, HBA1C Controls N & P

• 2 recalls, same reason

  • Terminated Z-0650-05 FDA Unclassified (pre-2012) ·initiated 15 Feb 2005
  • Terminated Z-0651-05 FDA Unclassified (pre-2012) ·initiated 15 Feb 2005

  The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.

510(k) Number

K952337 ↗

FDA Product Code

LCP

Device Class

Class II

Regulation

21 CFR Part 864.7470

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Abuscreen(R) Radioimmun for Cocaine Metabolite

  Class II

  FDA 510(k) K913722 Active Cleared 10 Sep 1991

• Cobas Core Immunochemistry System

  Class I

  FDA 510(k) K962231 Active Cleared 30 Aug 1996

• Roche Reagent for Apolipoprotein B

  Class I

  FDA 510(k) K910552 Active Cleared 7 May 1991

• Roche Abuscreen Ontrak Pos. Ref. Control-Methadone

  Class I

  FDA 510(k) K930844 Active Cleared 27 Jan 1994

• Ontrak Testcup Amphetamines

  Class II

  FDA 510(k) K962411 Active Cleared 7 Oct 1996

• Cobas Fp Reagen for Amikacin & Amikacin Calibrator

  Class II

  FDA 510(k) K852317 Active Cleared 25 Jun 1985

See all devices from Roche Diagnostic Systems, Inc. →