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ADVIA Centaur Tni-Ultra Assay recallZ-2207-2015 · Siemens Healthcare Diagnostics, Inc · initiated May 19, 2015

Class II Terminated All recalls posted in July 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

System-to-system bias between the Tni-Ultra assay on the ADVIA Centaur CP and ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems.

FDA root cause category: Under Investigation by firm

What the company is doing

Siemens sent an Urgent Medical Device Correction letter dated via Federal Express to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Field Correction Effectiveness Check attached to the letter. For questions contact your Siemens Customer Care Center or your local Siemens technical support representative.

Recall details

Recall number
Z-2207-2015
Recall class
Class II
Status
Terminated
Initiated by the company
May 19, 2015
Posted by the FDA
Jul 23, 2015
Recalling firm
Siemens Healthcare Diagnostics, Inc
Quantity
SMN10317708 = 20544 kits & SMN 10317709 = 21159 kits
Product code
MMI
FDA submissions
K053020
Distribution
Worldwide distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, MS, MT, NC, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, and Puerto Rico; and the countries of Algeria, Austria, Bahrain, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Iceland, Indonesia, Ireland, Italy, Jordan, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, Norway, Pakistan, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, AR, AU, BD, BR, CA, CL, CN , CO, CR, DO, EC, HK, ID, IE, IL, IN, JP, KR, LK, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, TH, TW, UY, VN, and ZA.

Product description

ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems. Cardiac troponin I determinations aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

***This field action applies to all in-date lots of reagents (Kit lots ending in 088, 089, 090, 091, 093 and 094) and all future lots until the issue is resolved and a follow-up communication is issued by Siemens.****  SMN 10317708 - 100 tests 43796099 May 25, 2015 43818088 May 25, 2015 44793088 May 25, 2015 45687089 June 22, 2015 46527089 June 22, 2015 48096089 June 22, 2015 49216090 August3, 2015 50779090 August3, 2015 52113091 September 14, 2015 53091093 October 19, 2015 54684093 October 19, 2015  SMN 10317709 -500 tests 43797088 May25, 2015 43819088 May25,2015 44098088 May25, 2015 44623088 May 25, 2015 45688089 June 22, 2015 46661089 June 22, 2015 48301090 August3, 2015 49869090 August 3, 2015 50884091 September 14, 2015 51471091 September 14, 2015 51798091 September 14, 2015 53092093 October 19,2015 53231093 October 19,2015 54742094 December 6, 2015

Other devices under the same FDA submission

4 devices cleared under K053020 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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