Alinity 07P8421Recalls & reported problems
Abbott GmbH · Alinity i Anti-HBc Reagent Kit 200 Tests · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740136659), received between Apr 2, 2026 and Apr 2, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative Result” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- False Negative Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2026False Negative Result
THE CUSTOMER OBSERVED FALSE NEGATIVE ALINITY I ANTI-HBC RESULTS. ON (B)(6) 2026, SID (B)(6) (MALE, 69 YEARS OLD) WAS 0.95 S/CO GRAYZONE, REPEATED 0.30 S/CO NONREACTIVE, 0.23 S/CO NONREACTIVE, 0.23 S/CO NONREACTIVE. THE SAME SAMPLE WAS REPEATED ON SERIAL (B)(6) WITH THE SAME REAGENT LOT 76110BE00. ON (B)(6) 2026 RESULT WAS 1.65 S/CO REACTIVE, 1.44 S/CO REACTIVE, 1.51 S/CO REACTIVE. IT IS UNKNOWN WHAT RESULT WAS REPORTED OUT OF LAB. REFERENCE LAB RESULT CAME BACK AS NONREACTIVE. ADDITIONALLY, THE CUSTOMER PULLED SAMPLES THAT ALREADY RESULTED FROM THIS INSTRUMENT AND RAN THEM ON SERIAL (B)(6), WITH DIFFERENT RESULTS FROM 2 SAMPLES. ON (B)(6) 2026, SID (B)(6) WAS 2.58 S/CO REACTIVE, REPEAT 0.69 NONREACTIVE, 2ND REPEAT 4.87 REACTIVE. SID (B)(6) WAS REPORTED AS REACTIVE, BUT ON (B)(6) 2026 REPEATED ON SERIAL (B)(6) RESULT OF 0.22 S/CO NONREACTIVE. ON (B)(6) 2026, SID (B)(6) WAS 1.43, 1.99 S/CO REACTIVE. SID (B)(6) WAS REPORTED AS REACTIVE BUT ON (B)(6) 2026 REPEATED ON SERIAL (B)(6) RESULT OF 0.74 S/CO NONREACTIVE. NORMAL REFERENCE RANGE OF <0.80 S/CO NONREACTIVE, GRAYZONE OF 0.80 TO <1.21 S/CO, REACTIVE OF = 1.21 S/CO. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24772037 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.