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ADVIA Centaur Systems TnI-Ultra assay recallZ-1991-2014 · Siemens Healthcare Diagnostics, Inc · initiated May 30, 2014

Class II Terminated All recalls posted in July 2014

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

The solid phase reagent in some of the ADVIA Centaur TnI -Ultra ReadyPacks, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.

FDA root cause category: Nonconforming Material/Component

What the company is doing

An Urgent medical Device Correction (UMDC) was mailed, via FedEx, to all affected Siemens Healthcare Diagnostics customers in the United States on May 30, 2014 for customer receipt on June 2, 2014. All international customers were provided with a copy of the Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each country's local regulations and procedures. Each customer is asked to complete a fax-back form. This notice informed the customers of the potential for incorrect control and patient results due to solid phase which is darker in appearance. The notice instructs customers to place one TnI-Ultra ReadyPack on the system at a time and to calibrate and run controls on each ReadyPack to ensure accurate control and patient values. Patient TnI-Ultra results produced with this assay are acceptable if they follow acceptable calibration with valid quality control results. Upon receipt of kit lots ending in 086 and higher, calibration of each ReadyPack is not required. This notice should be reviewed with the facility's laboratory or medical director.

Recall details

Recall number
Z-1991-2014
Recall class
Class II
Status
Terminated
Initiated by the company
May 30, 2014
Posted by the FDA
Jul 2, 2014
Recalling firm
Siemens Healthcare Diagnostics, Inc
Quantity
34,283 kits
Product code
MMI
FDA submissions
K053020
Distribution
Worldwide Distribution-USA (nationwide) including PR and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Canada, Mexico, Argentina, Austria, Australia. Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Great Britain, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Libya, Macedonia, Malaysia, ,Malta, Martinique, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Republic of Korea, Romania, Russian Federation, Serbia, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sri Lanka, South Africa, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, and Vietnam.

Product description

ADVIA Centaur Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790

Code information (models, lots, serial numbers)

Kit Lots Ending In: 078, 079, 082, 083, 084

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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