ALINITY I HAVAB IGG REAGENT KIT
Report
- Report Number
- 3002809144-2026-00019
- Event Type
- Malfunction
- Date Received
- January 23, 2026
- Date of Event
- January 10, 2026
- Report Date
- March 2, 2026
- Manufacturer
- ABBOTT GMBH
- Product Code
- LOL
- UDI-DI
- 00380740131333
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION ADDED TO FIELDS IN SECTION D4: LOT #, PRIMARY UDI NUMBER, AND EXPIRATION DATE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P26 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P27, AND 510K/PMA/BLA OF K113704 AND LIST NUMBER 6S93, HAVAB IGG II, AND 510K/PMA/BLA OF K222850. SECTION A PATIENT INFORMATION: NO PATIENT INFORMATION WAS PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORTED THE COMPLAINT ISSUE WITHOUT INDICATION OF ANY ADDITIONAL ISSUES. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 75248BE00. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I HAVAB IGG ASSAY DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS WITH LOT NUMBER 75248BE00 AND THE COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ALINITY I HAVAB IGG REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE NUMBER OF STANDARD DEVIATIONS TO CUTOFF AND PATIENT MEDIAN VALUES OF THE NEGATIVE POPULATION FOR THE COMPLAINT LOT ARE WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER¿S ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I HAVAB IGG, LOT NUMBER 75248BE00.
THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I HAVAB IGG RESULTS FOR ONE PATIENT. THE SAMPLE BELONGS TO A PATIENT IN INTENSIVE CARE WHO TESTED POSITIVE FOR CMV IGG. THE FOLLOWING DATA AS PROVIDED: ON (B)(6) 2026 THE HAVAB IGG RESULT WAS NONREACTIVE (VALUE NOT PROVIDED). A REPEAT SAMPLE WAS TAKEN ON (B)(6) 2026 AND THE ALINITY I HAVAB IGG RESULT WAS 2 S/CO (REACTIVE). (INTERPRETATION OF RESULTS = 1.00 IS REACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I HAVAB IGG RESULTS FOR ONE PATIENT. THE SAMPLE BELONGS TO A PATIENT IN INTENSIVE CARE WHO TESTED POSITIVE FOR CMV IGG. THE FOLLOWING DATA AS PROVIDED: ON (B)(6) 2026 THE HAVAB IGG RESULT WAS NONREACTIVE (VALUE NOT PROVIDED). A REPEAT SAMPLE WAS TAKEN ON (B)(6) 2026 AND THE ALINITY I HAVAB IGG RESULT WAS 2 S/CO (REACTIVE). (INTERPRETATION OF RESULTS = 1.00 IS REACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I HAVAB IGG RESULTS FOR ONE PATIENT. THE SAMPLE BELONGS TO A PATIENT IN INTENSIVE CARE WHO TESTED POSITIVE FOR CMV IGG. THE FOLLOWING DATA AS PROVIDED: ON (B)(6) 2026 THE HAVAB IGG RESULT WAS NONREACTIVE (VALUE NOT PROVIDED). A REPEAT SAMPLE WAS TAKEN ON (B)(6) 2026 AND THE ALINITY I HAVAB IGG RESULT WAS 2 S/CO (REACTIVE). (INTERPRETATION OF RESULTS = 1.00 IS REACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 465768 | ALINITY I HAVAB IGG REAGENT KIT | HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY) | LOL | ABBOTT GMBH | 75248BE00 | 00380740131333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6). |