Reported Jun 4, 2014 · Terminated

ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Number: 10282378.…

Siemens Healthcare Diagnostics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Healthcare Diagnostics, Inc · 333 Coney St · East Walpole, MA · 02032-1516

Is this the product you have?

    • ADVIA Centaur Systems TSH3 Ultra Ready Pack
    • 100
  • test Catalog Number06491072
  • Siemens Material Number10282378. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers
Lot codes and dates
  • Kit lots ending in/Exp Date266 17 April 2014 267 17 June 2014 269 01 August 2014 270 30 September 2014 271 18 November 2014 272 21 January 2015 273 18 November 2014
Amount recalled
22,770 kits

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Where it was sold

  • Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 27, 2016 · Data as of Sep 19, 4:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.