MAUDE Adverse Event Report: ASSORTED TESTING KITS

Device Problem Shelf Life Exceeded (1567)

Patient Problem No Code Available (3191)

Event Date 09/22/2015

Event Type  malfunction  

Event Description

I noticed that many expired medical tests are being sold on (b)(6).For example, this item: (b)(6) is an (b)(6) test clearly marked as expiring in january 2015 and thus offered "at a discount." please take action against those who put consumers at risk by intentionally selling expired medical tests.Thanks!.

• Brand Name: ASSORTED TESTING KITS
• Type of Device: ASSORTED TESTING KITS
• MDR Report Key: 5112588
• MDR Text Key: 27480593
• Report Number: MW5056595
• Device Sequence Number: 1
• Product Code: MVZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Report Date: 09/22/2015

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• Type of Device Usage: N
• Patient Sequence Number: 1