Dsl Active Prolactin Elisa Model 10-4500

• • Terminated Z-2047-2011 FDA Unclassified (pre-2012) ·initiated 3 Aug 2009

  The recall was initiated because Beckman Coulter has confirmed that the Active Prolactin ElLISA kit, lot number 890291 over estimates the expected dose values for patient serum samples due to a shift in the assigned calibrator values. Beckman Coulter recommends that patient results generated with the affected lot be evaluated in the context of other diagnostic tests and the clinical presentatio

510(k) Number

K960561 ↗

FDA Product Code

CFT

Device Class

Class I

Regulation

21 CFR Part 862.1625

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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