ADVIA Centaur HAV IgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A tes
FDA device recall Z-1119-2008 · posted 2008-05-06 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions Diagnostics
- Reason for recall
- Incorrect results: False reactive specimens on the ADVIA Centaur HAV IgM assay.
- Action taken
- Siemens issued a Urgent Field Safety Notiifcation (078D0709-01) to all Siemens Diagnostics Branches on 1/12/08 for communication to their customers. This Customer Bulletin/Urgent Field Safety Notification advises the customer of the problem and the actions to be taken to mitigate risk. A Confirmation fax-back form is included to ensure that all customers worldwide have been notified and have complied with the mandatory action.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LOL
- Quantity affected
- 49,533
- Distribution
- Worldwide Distribution - USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Chile, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Israel, Italy, Malaysia, Mexico, the
- Date initiated
- 2008-01-12
- Date posted
- 2008-05-06
- Date terminated
- 2012-06-20
- Location
- East Walpole, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER (K971418) | Chiron Diagnostics Corp. | 1997-07-17 |