Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer

• • Terminated Z-1553-2014 FDA Class II ·initiated 18 Feb 2014 ·on shared 510(k) K971418

  Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This may lead to the cover falling.

• • Terminated Z-1119-2008 FDA Unclassified (pre-2012) ·initiated 12 Jan 2008 ·on shared 510(k) K971418

  Incorrect results: False reactive specimens on the ADVIA Centaur HAV IgM assay.

• • Terminated Z-0645-2007 FDA Unclassified (pre-2012) ·initiated 9 Nov 2006 ·on shared 510(k) K971418

  Firm received complaints for signal 2 & 4 errors, and shifts in Relative Light Units (RLU). Investigations showed that the On-Board Stability (OBS) of the acid & base reagents may be compromised after 4 days after installation onto the Centaur CP system due to evaporation.

• • Terminated Z-1516-06 FDA Unclassified (pre-2012) ·initiated 4 Aug 2006 ·on shared 510(k) K971418

  Sample/Patient mis-identification (software defect)-the system can associate a test result and sample identification (SID) with an incorrect patient name when the Patient Demographics feature is used and the Patient Identification (PID) field is left blank

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

510(k) Number

K971418 ↗

FDA Product Code

MOI

Device Class

Class II

Regulation

21 CFR Part 866.6010

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Acs:centaur Afp

  Class II

  FDA 510(k) K981592 Active Cleared 7 Jul 1998

• Chiron Diagnostics ACS:180TU P

  Class II

  FDA 510(k) K970539 Active Cleared 24 Mar 1997

• Speciality Urine 1, 2

  Class I

  FDA 510(k) K971405 Active Cleared 16 Jun 1997

• Certain Complete Levels 1, 2, and 3; Cvm Levels 1, 2, 3, 4, and 5

  Class I

  FDA 510(k) K970956 Active Cleared 8 Apr 1997

• Chiron Diagnostics Acs: 180 Carbamazepine Assay

  Class II

  FDA 510(k) K964765 Active Cleared 14 Feb 1997

• Chiron Diagnostics Acs: 180 Folate

  Class II

  FDA 510(k) K991582 Active Cleared 30 Jun 1999

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