MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-31 for CF INPLEX ASR CARD 95-0501 manufactured by Hologic Incorporated.
[42534723]
Customers have experienced false positive results while testing patient samples using a cf inplex asr card. This product is an analyte specific reagent. The customer initially received (b)(6) for the impacted samples, but after re-extracting and re-testing the samples, the customer received normal/wt results. The incorrect results were experienced in lane eight of the impacted cards. There is no impact to patient results since the customer did not report incorrect results. Hologic is in the process of voluntarily recalling this product. Lot number u35 includes sublots u35bm, u35bj and u35bk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2016-00004 |
| MDR Report Key | 5539874 |
| Date Received | 2016-03-31 |
| Date of Report | 2016-03-31 |
| Date of Event | 2016-03-02 |
| Date Mfgr Received | 2016-03-02 |
| Date Added to Maude | 2016-03-31 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RON DOMINGO |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108167 |
| Manufacturer G1 | HOLOGIC INC |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CF INPLEX ASR CARD |
| Generic Name | ANALYTE SPECIFIC REAGENT, PRODUCT CODE |
| Product Code | MVU |
| Date Received | 2016-03-31 |
| Model Number | 95-0501 |
| Catalog Number | 95-0501 |
| Lot Number | U35BM, U35BJ AND U35BK |
| Device Expiration Date | 2016-11-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INCORPORATED |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-31 |