MAUDE Adverse Event Report: Siemens Healthcare Diagnostics, Inc. Atellica IM Toxoplasma IgG (Toxo G); Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Model Number	N/A
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction

• Brand Name: Atellica IM Toxoplasma IgG (Toxo G)
• Common Device Name: Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
• Manufacturer (Section D): Siemens Healthcare Diagnostics, Inc.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): Siemens Healthcare Diagnostics, Inc.; 333 coney st.; registration #1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; +1(508)298-5306
• MDR Report Key: 50140182
• Report Number: 1219913-2026-00158
• Device Sequence Number: 9408980
• Product Code: LGD
• UDI-Device Identifier: 00630414600123
• UDI-Public: (01)00630414600123(10)27001299(17)261121
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K012183
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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 Model Number: N/A
• Device Catalogue Number: 10995699
• Device Lot Number: 27001299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Female