MalfunctionQHR
ANTI-A (MURINE MONOCLONAL) GAMMA-CLONE
Received Mar 12, 2026 · Event occurred Feb 10, 2026
Report 1034569-2026-00010 · MDR key 24586419
Device
Generic name
Anti-a (murine Monoclonal) Gamma-clone
Manufacturer
Immucor, Inc.Catalog number
0410203
Lot number
104036
Product problems
- False Negative Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO INJURY OR HARM OCCURRED AS A RESULT OF THIS MALFUNCTION. NO SPECIFIC ROOT CAUSE OR DEFECT WAS IDENTIFIED. NO INSTRUMENT PROBLEM WAS IDENTIFIED. THERE IS NO SPECIFIC ACTION THAT USERS ARE EXPECTED TO TAKE TO MITIGATE THE REPORTED DEVICE FAILURE/MALFUNCTION. THE IMMUCOR INTERNAL REFERENCE FOR THE ASSOCIATED RECORD IS (B)(4).
Description of Event or Problem
ON (B)(6) 2026, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT FOR ANTI-A WITH ANTI-A (MURINE MONOCLONAL) GAMMA-CLONE.