Recall Z-0647-2013— Siemens Healthcare Diagnostics

Name: FDA recall Z-0647-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-28

Class III · Terminated

Class III FDA medical device recall by Siemens Healthcare Diagnostics, initiated 2012-11-28, terminated 2013-10-28. It names one FDA 510(k) clearance: K872305. Product: Immunoradiometric assay.. Reason: 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).

Recalling firm: Siemens Healthcare Diagnostics
Classification: Class III
Status: Terminated
Initiated: 2012-11-28
Terminated: 2013-10-28
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K872305 — IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSXDiagnostic Products Corp.·cleared 1987-07-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Immunoradiometric assay.

Reason for recall

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)

Data sourced from openFDA. This site is unofficial and independent of the FDA.