ALINITY S HIV AG/AB COMBO REAGENT KIT
Report
- Report Number
- 3002809144-2025-00344
- Event Type
- Malfunction
- Date Received
- November 3, 2025
- Date of Event
- September 17, 2025
- Report Date
- January 12, 2026
- Manufacturer
- ABBOTT GMBH
- Product Code
- QHM
- UDI-DI
- 00380740117184
- PMA / PMN Number
- BL125679
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE ALINITY S HIV AG/AB COMBO REAGENT LOT 74477BE00 IDENTIFIED NORMAL COMPLAINT ACTIVITY. RETURNED SAMPLE IDS (B)(6) WERE TESTED WITH ALINITY S HIV AG/AB COMBO REAGENT, LIST NUMBER 6P01-60, LOT 75200BE00 AND NONREACTIVE RESULTS WERE OBTAINED. FIELD DATA REVIEW SHOWED THAT THE REPEAT REACTIVE RATE OBSERVED FOR THE COMPLAINT LOT MEETS THE SPECIFICITY PERFORMANCE CLAIM OF THE PACKAGE INSERT. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. THE PERFORMANCE OF THE LIKELY CAUSE LOT WAS INVESTIGATED BY COMPLETING A REVIEW FOR NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES AND DEVIATIONS RELATED TO THE LIKELY CAUSE LOTS. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. THE ALINITY S HIV AG/AB COMBO ASSAY IS PERFORMING AS EXPECTED AND NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.
AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. UPDATED SECTION B5.
UPON REVIEW, IDENTIFIED AN ERROR WITH SECTION D9 - DATE RETURNED TO MFR: CORRECTED TO UPDATE THIS FIELD FROM 11/11/2025 TO BLANK.
AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. SECTION A1 PATIENT IDENTIFIER SIDS: (B)(6).
THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB COMBO RESULTS ON MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: (B)(60 2025 SID (B)(6) = 5.12 / 1.83 / 5.79 / 0.35 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE, (B)(6) 2025 SID (B)(6) = 14.27 / 48.51 / 72.05 / 0.42 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 259.76 / 243.47 / 231.68 / 230.5 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 240.04 / 227.62 / 236.70 / 281 S/CO; BIORAD GENIUS WAS REACTIVE; NAT WAS NEGATIVE, SID (B)(6) = 364.89 / 300.76 / 285.35 / 372.4 S/CO; BIORAD GENIUS WAS REACTIVE; NAT WAS NEGATIVE, SID(B)(6) = 7.23 / 5.09 / 5.09 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = REPEAT REACTIVE, REPEAT RESULT = 35 S/CO; BIORAD GENIUS AND NAT WERE NEGATIVE, SID (B)(6) = 45.50 / 45.75 / 49.93 / 0.11 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 5.72 / 1.75 / 6.15 / 0.07 S/CO; BIORAD GENIUS AND NAT WERE NEGATIVE, SID (B)(6) = 5.14 / 6.16 / 8.69 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB COMBO RESULTS ON MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) = 5.12 / 1.83 / 5.79 / 0.35 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE. (B)(6) 2025 SID (B)(6) = 14.27 / 48.51 / 72.05 / 0.42 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE. SID (B)(6) = 259.76 / 243.47 / 231.68 / 230.5 S/CO; BIORAD GENIUS WAS NEGATIVE. SID (B)(6) = 240.04 / 227.62 / 236.70 / 281 S/CO; BIORAD GENIUS WAS REACTIVE; NAT WAS NEGATIVE. SID (B)(6) = 364.89 / 300.76 / 285.35 / 372.4 S/CO; BIORAD GENIUS WAS REACTIVE; NAT WAS NEGATIVE. SID (B)(6) = 7.23 / 5.09 / 5.09 S/CO; BIORAD GENIUS WAS NEGATIVE. SID (B)(6) = REPEAT REACTIVE, REPEAT RESULT = 35 S/CO; BIORAD GENIUS AND NAT WERE NEGATIVE. SID (B)(6) = 45.50 / 45.75 / 49.93 / 0.11 S/CO; BIORAD GENIUS WAS NEGATIVE. SID (B)(6) = 5.72 / 1.75 / 6.15 / 0.07 S/CO; BIORAD GENIUS AND NAT WERE NEGATIVE. SID (B)(6) = 5.14 / 6.16 / 8.69 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB COMBO RESULTS ON MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025, SID (B)(6) = 5.12 / 1.83 / 5.79 / 0.35 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE, (B)(6) 2025, SID (B)(6) = 14.27 / 48.51 / 72.05 / 0.42 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 259.76 / 243.47 / 231.68 / 230.5 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 240.04 / 227.62 / 236.70 / 281 S/CO; BIORAD GENIUS WAS REACTIVE; NAT WAS NEGATIVE, SID (B)(6) = 364.89 / 300.76 / 285.35 / 372.4 S/CO; BIORAD GENIUS WAS REACTIVE; NAT WAS NEGATIVE, SID (B)(6) = 7.23 / 5.09 / 5.09 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = REPEAT REACTIVE, REPEAT RESULT = 35 S/CO; BIORAD GENIUS AND NAT WERE NEGATIVE, SID (B)(6) = 45.50 / 45.75 / 49.93 / 0.11 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 5.72 / 1.75 / 6.15 / 0.07 S/CO; BIORAD GENIUS AND NAT WERE NEGATIVE, SID (B)(6) = 5.14 / 6.16 / 8.69 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE , NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB COMBO RESULTS ON MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025, SID (B)(6) = 5.12 / 1.83 / 5.79 / 0.35; BIORAD GENIUS WAS NEGATIVE, ON (B)(6) 2025, SID (B)(6) = 14.27 / 48.51 / 72.05 0.42 / S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 259.76 / 243.47 / 231.68 / 230.5 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 240.04 / 227.62 / 236.70 / 281 S/CO; BIORAD GENIUS WAS REACTIVE; NAT WAS NEGATIVE, SID (B)(6) = 364.89 / 300.76 / 285.35 / 372.4 S/CO; BIORAD GENIUS WAS REACTIVE; NAT WAS NEGATIVE, SID (B)(6) = 7.23 / 5.09 / 5.09 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = REPEAT REACTIVE, REPEAT RESULT = 35 S/CO; BIORAD GENIUS AND NAT WERE NEGATIVE, SID (B)(6) = REPEAT REACTIVE; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = REPEAT REACTIVE; BIORAD GENIUS AND NAT WERE NEGATIVE, SID (B)(6) = REPEAT REACTIVE; BIORAD GENIUS WAS NEGATIVE, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1020062 | ALINITY S HIV AG/AB COMBO REAGENT KIT | SEROLOGY TESTS USED FOR INFECTIOUS DISEASE SCREENING OF BLOOD AND PLASMA DONATIO | QHM | ABBOTT GMBH | 75200BE00 | 00380740117184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ALNTY S SYSTEM, 06P16-01, (B)(6) |