Alinity 08P0521Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740130657), received between May 14, 2024 and Aug 10, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (P050042); they may or may not involve this specific model.

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.

Recalls naming this device

1. Mar 4, 2024Open, Classified

   Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).

   Z-1480-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026False Negative Result

  The customer observed false nonreactive Alinity i Anti-HCV results on a patient. The results provided were:Initial=0.33 S/CO (< 1.00 S/CO=nonreactive) /repeated =0.33 and 0.34 S/COPrevious history in APRIL on Cobas Platform=6.88.There was no reported impact to patient management.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50195581 ↗
• MalfunctionMay 14, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NONREACTIVE ALINITY I ANTI-HCV RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 SID (B)(6) = 0.40 S/CO, REPEATED (B)(6) 2024 ON ARCHITECT = 5.59 / 5.46 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19311120 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P050042. One submission often covers many models, so check the product and lot details in each record.

• Z-1479-2024 · Mar 4, 2024 · Open, Classified
  ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
• Z-0413-2007 · Jan 2, 2007 · Terminated
  ARCHITECT i System Assay CD-ROM, in vitro diagnostic analyzer, U.S. Version 21.0; for use on the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list number 06E58-2