MAUDE Adverse Event Report: LEE LABORATORIES, INC. BD DIFCO¿ SALMONELLA O ANTISERUM FACTOR 7; ANTISERA, ALL GROUPS, SALMONELLA SPP.

Catalog Number	228161
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using the antisera, all groups, salmonella spp.An unspecified number of patient samples failed to agglutinate.No health impact or consequence reported.
Event or Problem Description
It was reported while using the antisera, all groups, salmonella spp.An unspecified number of patient samples failed to agglutinate.No health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary: no return samples were received to investigate this complaint.To investigate the complaint on catalog 228161, lot 4270060, according to the products instructions for use, using available culture representing salmonella o antiserum factor 7 group c1.For the antiserum test, a portion of the culture was removed from the agar plate and mixed into one drop of antiserum on a slide.In addition, the culture was tested in a drop of saline to check for roughness.Each slide was rotated for one minute before reading the reaction.Results were as follows: 4+ reactions were observed at undiluted.No reactivity was observed when the culture was tested in saline.Based on the testing performed the complaint was not confirmed.To further investigate the batch history record of the product lot was reviewed.The batch history record review indicated no discrepancies, and all release testing was satisfactory.Complaint trends were also reviewed covering a three-year period.There have been no other complaints received on the lot number in the period reviewed.

• Brand Name: BD DIFCO¿ SALMONELLA O ANTISERUM FACTOR 7
• Common Device Name: ANTISERA, ALL GROUPS, SALMONELLA SPP.
• Manufacturer (Section D): LEE LABORATORIES, INC.; 1475 athens highway; grayson GA 30017
• Manufacturer (Section G): LEE LABORATORIES, INC.; 1475 athens highway; grayson GA 30017
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 23383833
• Report Number: 1025402-2025-00011
• Device Sequence Number: 8689828
• Product Code: GRM
• UDI-Device Identifier: 00382902281610
• UDI-Public: (01)00382902281610(17)280313(10)4270060
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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 Catalogue Number: 228161
• Device Lot Number: 4270060
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown