MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-05 for CF INPLEX ASR CARD 95-0501 manufactured by Hologic, Inc..
[42553437]
Customers have experienced false positive results while testing patient samples using a cf inplex asr card. The customer received het for s549r a>c or het / eq for y122x and y1092x c>a. The incorrect results were experienced in lane eight of the impacted cards. Hologic voluntarily recalled this product on 4/1/2016 with a report of corrections and removals.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2016-00006 |
| MDR Report Key | 5549036 |
| Date Received | 2016-04-05 |
| Date of Report | 2016-04-05 |
| Date of Event | 2016-03-07 |
| Date Mfgr Received | 2016-03-07 |
| Date Added to Maude | 2016-04-05 |
| 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 | MVU |
| Date Received | 2016-04-05 |
| Model Number | 95-0501 |
| Catalog Number | 95-0501 |
| Lot Number | U35AP AND U35BC |
| Device Expiration Date | 2016-10-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2016-04-05 |