MAUDE Adverse Event Report: ABBOTT BINAXNOW; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 213015

Device Problems Expiration Date Error (2528); Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 04/26/2023

Event Type  malfunction  

Event Description

Lot number and expiration date on outside label and inside packing are different.Both inside test packets expire 11-17-2023, (lot number 213015), but the outside label notes an expiration date of 5-14-2024 (lot number 215093).It is very likely that anyone who purchased this product, looking only at the outside packaging labeling, would anticipate the expiration date is 6 months after the kit actually expired.During that 6 month window the patient would unknowing be given invalid results.I am submitting this as this is not an easy mistake to make, and may identify either a one time mistake, or a serious systemic packing error.Reference report mw5117127.

• Brand Name: BINAXNOW
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 16843244
• MDR Text Key: 314402028
• Report Number: MW5117126
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/17/2023
• Device Lot Number: 213015
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1