Dsl I-Pth (Dsl #8000)

• • Terminated Z-0585-2011 FDA Unclassified (pre-2012) ·initiated 22 Apr 2010

  The recall was initiated because Beckman Coulter has confirmed that the stated stability of the DSL-10-8000 I-PTH ELISA and DSL-8000 I-PTH IRMA assays may not be achieved for the lot numbers affected by the recall. The affected I-PTH ELISA and the I-PTH IRMA kit lots may produce falsely elevated patient results. Internal stability testing showed an average 16% elevation for I-PTH ELISA lot 99

510(k) Number

K896294 ↗

FDA Product Code

CEW

Device Class

Class II

Regulation

21 CFR Part 862.1545

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Dsl Active Shbg (Dsl 7400)

  Class I

  FDA 510(k) K915823 Active Cleared 17 Mar 1992

• Active T3 Ria

  Class II

  FDA 510(k) K960550 Active Cleared 6 Mar 1996

• Dsl Beta 2 Microglobulin (Dsl 6200)

  Class II

  FDA 510(k) K911881 Active Cleared 10 Sep 1991

• Active Crosslaps Elisa

  Class I

  FDA 510(k) K960171 Active Cleared 28 Mar 1996

• Dsl Aactive Dhea Eia Kit

  Class I

  FDA 510(k) K955114 Active Cleared 23 Feb 1996

• Dsl Insulin Ria (Dsl 1600)

  Class I

  FDA 510(k) K914820 Active Cleared 9 Jan 1992

See all devices from Diagnostic Systems Laboratories, Inc. →