Recall Z-0353-2007 ยท LEG Enzyme Immunoassay, Valproic Acid
Bayer Healthcare, LLC (Diagnostics Division)
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 this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline.
| Date | Jan 17, 2007 (initiated Sep 8, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 Bul |
| Quantity | 1184 instruments total, all products |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990346 | BAYER ADVIA 1650 CHEMISTRY SYSTEM Bayer Corp., May 21, 1999 |