MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for ARCHITECT HAVAB-G 6L27-25 06L27-25 manufactured by Abbott Gmbh.
[187556995]
Correction/removal number= 3002809144-03/16/20-002-r. Investigation into the issue confirmed a performance shift for the architect havab-g impacted reagent lots due to the erroneous concentration for hepatitis a virus that was utilized during manufacture, which has the potential to generate falsely elevated control and patient sample results. An internal study using anti-hav negative patient samples was conducted and determined that results that fall in the range of 1. 00 - 1. 72 s/co have the potential to be falsely reactive. A product recall letter has been issued to all customers who have received the impacted lots 03429be00, 06172be00, 08073be00, and 10353be00. The product recall letter instructs the customer to immediately discontinue the use of, and destroy, any remaining inventory of the specific 4- architect havab-g reagent lots and instructs the customer to contact customer support for replacement material in the event if they were currently using or have inventory of one of the impacted lots.
Patient Sequence No: 1, Text Type: N, H10
[187556996]
The customer reported the negative quality control is recovering out of range high while using the architect havab-g reagent. The customer stated that the results were greater than the negative cutoff of 1. 0 s/co. There was no patient involvement and no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2020-00261 |
| MDR Report Key | 9905632 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2019-04-08 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTIAN LEE |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224668-294 |
| Manufacturer G1 | ABBOTT GMBH |
| Manufacturer Street | MAX-PLANCK-RING 2 |
| Manufacturer City | WIESBADEN 65205 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65205 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 3002809144-03/16/20-002- |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT HAVAB-G |
| Generic Name | IGG ANTI-HAV |
| Product Code | LOL |
| Date Received | 2020-03-31 |
| Model Number | 6L27-25 |
| Catalog Number | 06L27-25 |
| Lot Number | 03429BE00 |
| Device Expiration Date | 2020-03-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT GMBH |
| Manufacturer Address | MAX-PLANCK-RING 2 WIESBADEN 65205 GM 65205 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |