MAUDE Adverse Event Report: HOLOGIC, INC. CF INPLEX ASR CARD; ANALYTE SPECIFIC REAGENT

Model Number 95-0501

Device Problems False Positive Result (1227); Nonstandard Device (1420)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2016

Event Type  malfunction  

Event Description

Customers have experienced false positive results while testing patient samples using a cf inplex asr card.The customer received false positive het for (b)(4).Hologic voluntarily recalled this product on 4/1/2016 with a report of corrections and removals.

• Brand Name: CF INPLEX ASR CARD
• Type of Device: ANALYTE SPECIFIC REAGENT
• Manufacturer (Section D): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: ron domingo ; 10210 genetic center drive; san diego, CA 92121 ; 8584108167
• MDR Report Key: 5557498
• MDR Text Key: 42871836
• Report Number: 2024800-2016-00009
• Device Sequence Number: 1
• Product Code: MVU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/01/2016
• Device Model Number: 95-0501
• Device Catalogue Number: 95-0501
• Device Lot Number: U35BA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 04/07/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening