Active Intact Pth Elisa

• • Terminated Z-0584-2011 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

• • Terminated Z-0107-2011 FDA Unclassified (pre-2012) ·initiated 4 Mar 2010

  The recall was initiated after Beckman Coulter confirmed that the stated stability of the DSL-10-8000 I-PTH ELISA assay may not be achieved for lot numbers: 891198, 990980 and 991448. The kit lot numbers listed above passed the stability testing performed at 6 months, but failed the testing performed at 12 months. Therefore the affected I-PTH ELISA kit lots may produce falsely elevated patient r

510(k) Number

K952199 ↗

FDA Product Code

CEW

Device Class

Class II

Regulation

21 CFR Part 862.1545

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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