ADVIA 1650 Chemistry System, Automated Clinical Chemistry… recallZ-0352-2007 · Bayer Healthcare, LLC (Diagnostics Division) · initiated Sep 8, 2006

Why it was recalled

Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery observed by the customer was approximately -25%. Investigation into this issue was initiated promptly following receipt of this complaint.

FDA root cause category: Software design

What the company is doing

On 9/08/06, a Support Bulletin was sent to all affected Bayer HealthCare LLC Branches in order to inform them of the issue and to provide them with instructions for the 'field correction'. On 9/08/06, a Customer Bulletin was sent to all affected Bayer HealthCare LLC Branches both in the US and worldwide for communication with the affected end user customers. The bulletin advises of the problem and the corrective action. A Completion Confirmation (Fax-back) Form was included to ensure that all customers worldwide have been notified and have complied with the mandatory action. The Customer Bulletin is to be sent to all affected end user customers. Bayer Technical Service Specialists will follow-up with all of the ADVIA Chemistry System customers to make sure they have understood the bulletin and to ask that they return the FAX-back Completion Confirmation Form to Bayer HealthCare. If Bayer HealthCare does not receive the form in a timely manner, specialists in the Bayer Technical Care Center will contact the customer through whatever means possible in an effort to obtain 100% effectiveness on this communication.

Recall details

Recall number

Z-0352-2007

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Sep 8, 2006

Posted by the FDA

Jan 17, 2007

Recalling firm

Bayer Healthcare, LLC (Diagnostics Division)

Quantity

1184 instruments total, all products

Product code

LEG

FDA submissions

K990346

Distribution

Worldwide, including USA, Puerto Rico, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, Spain, Saudi Arabia, Sweden, Switzerland, Syria, Taiwan, Turkey, and United Kingdom.

Product description

ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline.

Other devices under the same FDA submission

2 devices cleared under K990346 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• ADVIA® Chemistry XPT System 10723034

  Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  1 recall174 reports
• ADVIA® 1800 Analyzer 10315183

  Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  150 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 36713).

• Z-0351-2007 · Terminated
  ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of th…
• Z-0353-2007 · Terminated
  ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of th…