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ADVIA Centaur XP Immunoassay System, Catalog… recallZ-2663-2014 · Siemens Healthcare Diagnostics · initiated Aug 13, 2014

Class II Terminated All recalls posted in September 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 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 firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems. Pushing the sample racks may cause misreads of Sample IDs (SID) if the sample rack loading instructions are not followed exactly as described in the ADVIA Centaur or ADVIA Centaur XP Operators Guide.

FDA root cause category: Software design (manufacturing process)

What the company is doing

The firm, Siemens, sent "Urgent Medical Device Correction" Letters (dated 8/13/2014) to their consignees/customers informing them of the issue and actions to be taken. Field service personnel were sent a Support Bulletin describing the issue and instructing them how to deal with customer questions. The UFSN must be used by customers as an addendum to the system operating instructions until further notice. The consignees/customers were also instructed to review this letter with your Medical Director; complete and return the attached FIELD CORRECTION EFFECTIVENESS CHECK within 30 days via fax to the Customer Care Center at (302) 631-7597; retain the letter with your laboratory records and forward the letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center, your local Siemens technical support representative and/or call 914-524-2868.

Recall details

Recall number
Z-2663-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 13, 2014
Posted by the FDA
Sep 18, 2014
Recalling firm
Siemens Healthcare Diagnostics
Quantity
10,515 (Domestic: 2771; Foreign: 7744) in total
Product code
JJE
FDA submissions
K041133
Distribution
Worldwide Distribution: US (nationwide) and countries of: Argentina, Austria, Australia, Bahrain, Bangladesh, Belgium, Belgrade, Brazil, Botswana, Canada, Chile, China, Colombia, Croatia, Czech Republic, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Georgia, Great Britain, Hungary, Indonesia, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kazakstan, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, New Caledonia, Netherlands, Norway, New Zealand, Pakistan, French Polynesia, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, Vatican, Venezuela, Vietnam, Yemen, and Zimbabwe.

Product description

ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696, 10471899 --- For in vitro diagnostic use This immunoassay system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.

Code information (models, lots, serial numbers)

All Serial Numbers

Other devices under the same FDA submission

4 devices cleared under K041133 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 69074).

Sources and updates

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