MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2008-08-28 for CLINICAL CHEMISTRY AST-ACTIVATED 8L91-40 manufactured by Abbott Manufacturing, Inc..
| Report Number | 2018433-2008-00176 |
| MDR Report Key | 1145536 |
| Report Source | 01,05 |
| Date Received | 2008-08-28 |
| Date of Report | 2008-03-20 |
| Date of Event | 2008-03-20 |
| Date Mfgr Received | 2008-12-18 |
| Device Manufacturer Date | 2007-12-03 |
| Date Added to Maude | 2009-01-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. KHAUDEJA BANO |
| Manufacturer Street | 100 ABBOTT PARK ROAD D09Y6, AP6C-2 |
| Manufacturer City | ABBOTT PARK IL 600646112 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646112 |
| Manufacturer Phone | 8479386319 |
| Manufacturer G1 | ABBOTT MANUFACTURING, INC. |
| Manufacturer Street | 820 MISSION ST. |
| Manufacturer City | SOUTH PASADENA CA 91030 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91030 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | 2018433-08/07/08-003-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINICAL CHEMISTRY AST-ACTIVATED |
| Generic Name | FOR THE QUANTITATION OF ASPARTATE AMINOTRANSFERASE IN HUMAN SERUM OR PLASMA |
| Product Code | CIT |
| Date Received | 2008-08-28 |
| Model Number | NA |
| Catalog Number | 8L91-40 |
| Lot Number | 59031HW00 |
| ID Number | NA |
| Device Expiration Date | 2008-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US 91030 |