Recalls / —

—#126652

Product

ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.

FDA product code

JLW — Radioimmunoassay, Thyroid-Stimulating Hormone

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K110586

Affected lot / code info

Kit lots ending in/Exp Date: 266 17 April 2014 267 17 June 2014 269 01 August 2014 270 30 September 2014 271 18 November 2014 272 21 January 2015

Why it was recalled

Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

Root cause (FDA determination)

Device Design

Action the firm took

Siemens Healthcare Urgent Medical Device Correction (UMDC) was mailed to all affected Siemens Healthcare Diagnostics customers in the United States on April 11, 2014 for customer receipt on April 14, 2014. This notice informed the customers of fluorescein interference with the ADVIA Centaur Systems TSH3-Ultra and Vitamin D Total assays. This notice instructs customers that the TSH3-Ultra and Vitamin D assays can continue to be used for testing any sample that does not contain fluorescein. However, testing blood drawn from a patient, without allowing clearance of fluorescein is not recommended. This notice should be reviewed with the facility's laboratory or medical director. B. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on April 10, 2014. This notice informed the customer of fluorescein interference with the ADVIA Centaur Systems TSH3-Ultra , Vitamin D Total and ADVIA Centaur BRAHMS Procalcitonin assays. This notice instructs customers that the TSH3-Ultra, Vitamin D and Procalcitonin assays can continue to be used for testing any sample that does not contain fluorescein. However, testing blood drawn from a patient, without allowing clearance of fluorescein is not recommended. This notice should be reviewed with the facilitys laboratory or medical director. (Note: The ADVIA Centaur BRAHMS Procalcitonin assay is not sold in the US.)

Recalling firm

Firm

Siemens Healthcare Diagnostics, Inc

Address

333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Afghanistan Algeria Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Canary Islands Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iceland Iran Iraq Ireland Israel Italy Jordan Kazakhstan Latvia Lebanon Lithuania Luxembourg Macedonia Malta Netherlands Norway Oman Pakistan Poland Portugal Qatar Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir. Vatican Yemen.

Timeline

Recall initiated

2014-04-10

Posted by FDA

2014-05-23

Terminated

2016-05-27

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #126652. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.