MalfunctionGRM
BD DIFCO¿ SALMONELLA O ANTISERUM GROUP A FACTORS 1, 2, 12
Received Apr 27, 2026 · Event occurred Mar 30, 2026
Report 1025402-2026-00001 · MDR key 24998477
Device
Generic name
Antisera, All Groups, Salmonella Spp.
Manufacturer
Lee Laboratories, Inc.Catalog number
229471
Lot number
3166226
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Description of Event or Problem
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.