Alinity m 09N85-095Recalls & reported problems
Abbott Molecular Inc. · Alinity m BKV AMP Kit · Class 2
All models of Alinity m (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00884999050709), received between Sep 23, 2026 and Sep 23, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test Results” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Low Test Results1
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.
MalfunctionSep 23, 2026Low Test Results
The customer reported a misquantitation low result while using the Alinity m BKV assay. The customer stated that their BKV results appear lower when compared to results obtained on another platform; however, they were unable to specify which platform was used for comparison. The customer also indicated that this situation is not considered a discrepancy at this time. The customer stated that the issue was not so much about any one questionable result, but rather an inquiry to demonstrate that the instrument and the assay are performing within expectations. The laboratory manager forwarded an email from the medical director of the Kidney Transplantation from (b)(6) 2026, in which it was stated they were "seeing a worrying trend with biopsy proven polyoma nephropathy with pretty low titers BK PCR performed at DLO/Quest labs (this site). There is a concern that the DLO/Quest PCR is not correlating well with other standard labs. A patient had biopsy proven polyoma nephropathy despite low titers BK PCR. JC PCR is negative. The patient was recently admitted to the hospital and had a BK PCR sent by mistake to ViraCor (another diagnostic company) and the titers were almost 7 times more tha
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872763 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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