Active Inhibin-a Elisa, Model Dsl-10-28100

• 4 recalls, same reason

  • Terminated Z-2774-2011 FDA Unclassified (pre-2012) ·initiated 31 Mar 2011
  • Terminated Z-2772-2011 FDA Unclassified (pre-2012) ·initiated 31 Mar 2011
  • Terminated Z-2775-2011 FDA Unclassified (pre-2012) ·initiated 31 Mar 2011
  • Terminated Z-2773-2011 FDA Unclassified (pre-2012) ·initiated 31 Mar 2011

  The recall was initiated because patient results are falsely elevated by approximately 30% because the reference standard of the Manual Inhibin A ELISA assay has shifted from the assays original calibration. Erroneously elevated results may lead to unnecessary ultrasound testing to confirm gestational age, patient psychological stress until diagnostic testing is completed, and/or medical decis

510(k) Number

K002128 ↗

FDA Product Code

NDR

Device Class

Class I

Regulation

21 CFR Part 862.1260

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class I

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  FDA 510(k) K960550 Active Cleared 6 Mar 1996

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  Class II

  FDA 510(k) K911881 Active Cleared 10 Sep 1991

• Active Crosslaps Elisa

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• Dsl Aactive Dhea Eia Kit

  Class I

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• Dsl Insulin Ria (Dsl 1600)

  Class I

  FDA 510(k) K914820 Active Cleared 9 Jan 1992

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