MAUDE Adverse Event Report: LEE LABORATORIES, INC. BD DIFCO¿ SALMONELLA O ANTISERUM GROUP A FACTORS 1, 2, 12; ANTISERA, ALL GROUPS, SALMONELLA SPP.

Catalog Number	229471
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	03/30/2026
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 bd difco¿ salmonella o antiserum group a factors 1, 2, 12 the user noted an unspecified number of patient test results had weak reactivity.The user stated that microscopic examination was required.No health impact or consequence reported.

• Brand Name: BD DIFCO¿ SALMONELLA O ANTISERUM GROUP A FACTORS 1, 2, 12
• 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: 24998477
• Report Number: 1025402-2026-00001
• Device Sequence Number: 9813760
• Product Code: GRM
• UDI-Device Identifier: 00382902294719
• UDI-Public: (01)00382902294719(17)270118(10)3166226
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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: Other
• Device Catalogue Number: 229471
• Device Lot Number: 3166226
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2023
• 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