MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT HEPATITIS IGG TEST; HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)

Device Problem False Positive Result (1227)

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

Event Type  malfunction  

Event Description

Abbott architect hepatitis a igg gave (b)(6) results on five pt samples.Abbott notified us of this possibility on wednesday march 11, 2020.We had been using affected lots of product dating back to (b)(6) 2019.Fda safety report id# (b)(4).

• Brand Name: ARCHITECT HEPATITIS IGG TEST
• Type of Device: HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
• Manufacturer (Section D): ABBOTT LABORATORIES
• MDR Report Key: 9853329
• MDR Text Key: 184481036
• Report Number: MW5093838
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1