MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for ARCHITECT HEPATITIS IGG TEST manufactured by Abbott Laboratories.
[184481036]
Abbott architect hepatitis a igg gave (b)(6) results on five pt samples. Abbott notified us of this possibility on wednesday march 11, 2020. We had been using affected lots of product dating back to (b)(6) 2019. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093838 |
| MDR Report Key | 9853329 |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-17 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT HEPATITIS IGG TEST |
| Generic Name | HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY) |
| Product Code | LOL |
| Date Received | 2020-03-18 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |