MAUDE Adverse Event Report: ACCESS BIO INCORPORATE CARESTART COVID-19 ANTIGEN TEST

Catalog Number RCHM-02071

Device Problems False Positive Result (1227); Output Problem (3005); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation is still going on.

Event Description

Laboratorio clinico irizarry guasch as several customers have complained that on some cartriges in the boxes of the ch23f01 the negatvie control develops a reddish line.

• Brand Name: CARESTART COVID-19 ANTIGEN TEST
• Type of Device: COVID-19 ANTIGEN TEST
• Manufacturer (Section D): ACCESS BIO INCORPORATE; 65 clyde rd suite a; somerset 08873
• MDR Report Key: 18871142
• MDR Text Key: 337304392
• Report Number: 3003966368-2024-00002
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA202625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RCHM-02071
• Device Lot Number: CH23F01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1