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	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer reports an observation of discordant toxoplasma igg (toxo g) results for a pregnant patient with reagent lot 298.The initial atellica im toxo g result (sample # (b)(6) on (b)(6) 2025) was reactive (positive).The result was reported to the physician and questioned.The sample was sent to other labs for alternate method testing.Results from the alternate methods were non-reactive (negative).A second sample from the same patient was drawn on a different date (sample # (b)(6) on (b)(6) 2026) and resulted positive with atellica im toxo g.The sample was sent to other labs for alternate method testing.Results from the alternate methods were non-reactive (negative).There are no allegations of patient or user intervention or adverse health consequences due to the event.Siemens is investigating.Note: this report is for reporting the discordant result obtained on (b)(6) 2025.A separate report is submitted for the discordant result obtained on (b)(6) 2026.
Event or Problem Description
The customer reports discordant toxoplasma igg (toxo g) results for a pregnant patient with reagent lot 298.The initial atellica im toxo g result (sample # (b)(6) on (b)(6) 2025) was reactive (positive).The result was reported to the physician and questioned.The sample was sent to other labs for alternate method testing.Results from the alternate methods were non-reactive (negative).A second sample from the same patient was drawn on a different date (sample # (b)(6) on (b)(6) 2026) and resulted positive with atellica im toxo g.The sample was sent to other labs for alternate method testing.Results from the alternate methods were non-reactive (negative).There are no allegations of patient or user intervention or adverse health consequences due to the event.

• 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: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 24301362
• Report Number: 1219913-2026-00033
• Device Sequence Number: 5240277
• Product Code: LGD
• UDI-Device Identifier: 00630414600123
• UDI-Public: (01)00630414600123(10)53871298(17)260616
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K012183
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 06/09/2026

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 Expiration Date: 06/16/2026
• Device Model Number: N/A
• Device Catalogue Number: 10995699
• Device Lot Number: 53871298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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: 28 YR
• Patient Sex: Female