Siemens Healthcare Diagnostics: Medical Device Recall in 2013 - (Recall #: Z-0648-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.

Product Classification:

Class III

Date Initiated: November 28, 2012

Date Posted: January 16, 2013

Recall Number: Z-0648-2013

Event ID: 63852

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)

Status: Terminated

Product Quantity: Lot 742= 8 units all foreign consignees) Lot 743=7 units (all foreign consignees)

Code Information:

Lots 742 and 743

Distribution Pattern:

Worldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico. Internationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay, Taiwan, and Uraguay,

Voluntary or Mandated:

Voluntary: Firm initiated