CF INPLEX ASR CARD 95-0501

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number2024800-2016-00006
MDR Report Key5549036
Date Received2016-04-05
Date of Report2016-04-05
Date of Event2016-03-07
Date Mfgr Received2016-03-07
Date Added to Maude2016-04-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactRON DOMINGO
Manufacturer Street10210 GENETIC CENTER DRIVE
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8584108167
Manufacturer G1HOLOGIC, INC.
Manufacturer Street10210 GENETIC CENTER DRIVE
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal Code92121
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCF INPLEX ASR CARD
Generic NameANALYTE SPECIFIC REAGENT
Product CodeMVU
Date Received2016-04-05
Model Number95-0501
Catalog Number95-0501
Lot NumberU35AP AND U35BC
Device Expiration Date2016-10-01
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC, INC.
Manufacturer Address10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121 US 92121


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2016-04-05

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