Irma-Count Tsh RKTS1, RKTS2, RKTS5, Rktsx

• 3 recalls, same reason

  • Terminated Z-0648-2013 FDA Class III ·initiated 28 Nov 2012
  • Terminated Z-0646-2013 FDA Class III ·initiated 28 Nov 2012
  • Terminated Z-0647-2013 FDA Class III ·initiated 28 Nov 2012

  The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H)

510(k) Number

K872305 ↗

FDA Product Code

JLW

Device Class

Class II

Regulation

21 CFR Part 862.1690

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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