Z-0647-2013Class III

Immunoradiometric assay

Name: Z-0647-2013 Immunoradiometric assay
Creator: Siemens Healthcare Diagnostics
Published: 2012-11-28
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-11-28 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics began a recall of Immunoradiometric assay on 2012-11-28. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0647-2013
Classification: Class III
Status: Terminated
Initiated: 2012-11-28
Posted: 2013-01-07
Terminated: 2013-10-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Immunoradiometric assay.
Product code: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
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)
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens sent an Urgent Medical Device Recall letter dated November 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product, complete and return the Urgent Medical Device Recall Effectiveness Check form included with the letter by fax to 302-631-7597. Customers were also instructed to determine their replacements needed, and to forward the recall letter to whomever they may have distributed the affected product. For questions customers were instructed to contact their Siemens Technical Solutions Ceter or their local technical support representative. For questions regarding this recalla call 914-524-2955.
Quantity in commerce: Lot 831=19 units (all foreign consignees) and Lot 832=2 units (all foreign consignees)
Distribution: 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,
Product codes and lots: Lots 831 and 832

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0647-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0646-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-07
Z-0647-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-07
Z-0648-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-07

Product code JLW

K872305Class IIIrma-Count Tsh Rkts1, Rkts2, Rkts5, RktsxDiagnostic Products Corp. / cleared 1987-07-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)