MAUDE Adverse Event Report: HOLOGIC INCORPORATED CF INPLEX ASR CARD; ANALYTE SPECIFIC REAGENT, PRODUCT CODE

Model Number 95-0501

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2016

Event Type  malfunction  

Event Description

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.

• Brand Name: CF INPLEX ASR CARD
• Type of Device: ANALYTE SPECIFIC REAGENT, PRODUCT CODE
• Manufacturer (Section D): HOLOGIC INCORPORATED; 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: 5539874
• MDR Text Key: 42534723
• Report Number: 2024800-2016-00004
• 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: Other
• Type of Report: Initial
• Report Date: 03/31/2016

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: U35BM, U35BJ AND U35BK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 03/31/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1