MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC HCG CASSETTE RAPID TEST; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number	B1077-22
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Control testing performed on the hcg urine cassette rapid test found that some of the kits from lot number hcg1022010 got a positive result on a negative control.(some from this lot did have acceptable quality control results.) this testing was control testing only.Internal recall of lot number hcg1022010 conducted and vendor contacted directly regarding issue.Samples from affected lot will be sent vendor for investigation.

• Brand Name: HCG CASSETTE RAPID TEST
• Common Device Name: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 13479725
• Report Number: 13479725
• Device Sequence Number: 20199214
• Product Code: JHI
• UDI-Device Identifier: 20885380020251
• UDI-Public: 20885380020251
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2022
• Report Date (Section F): 01/27/2022

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
• Operator of Device: Other
• Device Model Number: B1077-22
• Device Catalogue Number: B1077-22
• Device Lot Number: HCG1022010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 02/08/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/27/2022