Alinity 09P6901Recalls & reported problems
Abbott Laboratories · Alinity hs SLIDE MAKER STAINER MODULE · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740138868), received between Aug 27, 2024 and Sep 1, 2026 — classified as 2 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Low Test Results1
- Sparking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026Sparking
The customer observed a spark from a wire behind the stain baths of the Alinity HS Processing Module while removing the baths for cleaning that occurred overnight. After replacing the baths, the customer observed the spark again from the same wire.No impact to patient management and no impact to user safety was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50541584 ↗MalfunctionAug 27, 2024Low Test Results; Low Test Results
THE CUSTOMER OBSERVED NO BLAST FOUND FROM CELLAVISION FOR ONE KNOWN BLAST CELL PATIENT ON DIFFERENTIAL PREPARED BY THE ALINITY HS PROCESSING MODULE. THE CBC RESULTS GENERATED FROM ALINITY HQ PROCESSING MODULE WITH BLAST FLAGGING WHICH MATCHED THE PATIENT HISTORY. THE PATHOLOGIST QUESTIONED THE DIFFERENT RESULTS DUE TO NOT SEEN BLAST WITH KNOWN BLAST PATIENT. THE CUSTOMER STATED SMEAR HAS NO BLAST CELL DURING READING FROM CELLAVISION MICROSCOPE. THE CUSTOMER NOTICED SPECIMEN DROPPED INSIDE THE INSTRUMENT. THE ALINITY HS PROCESSING MODULE DID NOT GENERATE ANY FLAG FOR ERROR MESSAGE. THE CUSTOMER MADE MANUAL DIFFERENTIAL AND THAT CONFIRMED BLAST CELLS IN MANUAL PREPARED SMEAR. THE CUSTOMER AGREES WITH MANUAL DIFFERENTIAL RESULTS. THE BARCODE ID IS CORRECT ON SLIDE THAT MADE BY THE ALINITY HS PROCESSING MODULE. THE RESULTS PROVIDED WERE: (B)(6) 2024 SID (B)(6) WBC INITIAL=30.1 10E3/UL; HEMOGLOBIN INITIAL=7.56 G/DL; PLATELET INITIAL=21.2 10E3/UL; DIFFERENTIAL WITH LEFT SHIFT, VAR LYM AND BLAST FLAGS /NO REPEAT RESULTS PROVIDED. CELLAVISION= NO BLAST CELL IDENTIFIED. MANUAL DIFFERENTIAL=BLAST=37 THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20075336 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.