MAUDE Adverse Event Report: Quidel Corporation dba Ortho-Clinical Diagnostics SOFIA STREP A+ 25T, US

Catalog Number	20274
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/26/2026
Type of Reportable Event	Malfunction

• Brand Name: SOFIA STREP A+ 25T, US
• Common Device Name: SOFIA STREP A+ 25T, US
• Manufacturer (Section D): Quidel Corporation dba Ortho-Clinical Diagnostics; 100 indigo creek dr; rochester NY 14626
• Manufacturer Contact: nancy hewitson ; 100 indigo creek dr; rochester, NY 14626 ; +1(585)453-4165
• MDR Report Key: 50438178
• Report Number: 0002024674-2026-00103
• Device Sequence Number: 9362530
• Product Code: MCT
• UDI-Device Identifier: 30014613202745
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K171976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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: Health Professional
• Device Catalogue Number: 20274
• Device Lot Number: 238762
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/25/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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