Recall Z-1119-2008 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
Siemens Medical Solutions Diagnostics
ADVIA Centaur HAV IgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A test, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591.
| Date | May 6, 2008 (initiated Jan 12, 2008) |
| Status | Terminated |
| Reason | Incorrect results: False reactive specimens on the ADVIA Centaur HAV IgM assay. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 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 Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971418 | CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER Chiron Diagnostics Corp., Jul 17, 1997 |