Emit 2000 Phenobarbital Assay, Model OSR4D229

• • Terminated Z-0181-2014 FDA Class II ·initiated 30 Aug 2013

  Imprecision with certain lots

• • Terminated Z-0664-2013 FDA Class II ·initiated 10 Dec 2012

  Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R) Emit(R) 2000 Phenobarbital (4D019UL) lots E1, E2, and E3 as an application if the AU(R) System is used, the issue may be experienced. Firm has found that within-run imprecision of the recalled lots frequency of outliers that differ from the expected value by 20%. This is an expansion of

• • Terminated Z-0030-2013 FDA Class II ·initiated 30 Jul 2012

  Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. Also, if the Syva(R) Emit(R) 2000 Phenobartbital Assay (4D019UL) lots D4, D5, D6, and/or D7 as an application on AU(R) Systems is used, the issue may be experienced. Firm has found that within-run imprecison of the recalled lots when run on an AU(R) System may be higher that what would normally be obs

510(k) Number

K011528 ↗

FDA Product Code

DLZ

Device Class

Class II

Regulation

21 CFR Part 862.3660

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K810466 Active Cleared 6 Mar 1981

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  Class I

  FDA 510(k) K921747 Active Cleared 1 Oct 1992

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  Class I

  FDA 510(k) K861392 Active Cleared 13 Jun 1986

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  Class II

  FDA 510(k) K833623 Active Cleared 8 Dec 1983

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  Class II

  FDA 510(k) K800245 Active Cleared 3 Mar 1980

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