ADVIA Autoslide® Slide Maker Stainer 10282177Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414560595), received between Jul 14, 2017 and Jan 9, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  A SLIDE MADE FROM A TUBE WITH SAMPLE ID (B)(6) WAS MISLABELED AS SAMPLE ID (B)(6) BY AN ADVIA AUTOSLIDE SYSTEM. THE MANUAL DIFFERENTIAL COUNT OBTAINED FOR THE MISLABELED SLIDE DID NOT MATCH THE DIFFERENTIAL RESULTS OBTAINED ON AN ADVIA 2120I HEMATOLOGY SYSTEM FOR SAMPLE ID (B)(6). THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). TWO NEW SLIDES WERE PRODUCED WITH THE TUBE WITH SAMPLE ID (B)(6), AND THE RESULTS MATCHED THE DIFFERENTIAL RESULTS OBTAINED THE ADVIA 2120I HEMATOLOGY SYSTEM. THESE CORRECT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE MISLABELED SLIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9569061 ↗
• MalfunctionSep 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  A CUSTOMER REPORTED THAT A PANEL OF COMPLETE BLOOD COUNT (CBC) RESULTS OBTAINED ON A PATIENT SAMPLE, FROM A SLIDE PRODUCED BY AN ADVIA AUTOSLIDE SYSTEM, DID NOT CORRELATE WITH THE RESULTS OBTAINED ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. THE CUSTOMER REPORTED THAT THE RESULTS FROM THE ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER WERE EXPECTED. THE RESULTS OBTAINED FROM THE SLIDE PRODUCED ON THE ADVIA AUTOSLIDE SYSTEM WERE REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE CUSTOMER INDICATED THAT THE SLIDE PRODUCED BY THE ADVIA AUTOSLIDE SYSTEM WAS LABELED WITH THE CORRECTED SAMPLE ID, BUT CONTAINED ANOTHER PATIENT'S BLOOD SAMPLE. THE CUSTOMER MANUALLY CREATED A SLIDE USING THE AFFECTED PATIENT SAMPLE AND STAINED IT USING A HEMATEK INSTRUMENT; THE RESULTS OBTAINED FROM THE MANUALLY PRODUCED SLIDE CONFIRMED THE RESULTS OBTAINED ON THE ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INCORRECT PATIENT'S BLOOD SAMPLE PRODUCED ON ANOTHER PATIENT'S SLIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7866469 ↗
• MalfunctionJul 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAMPLE (B)(6) (PATIENT A) AND SAMPLE (B)(6) (PATIENT B) WERE RUN ON THE ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. BOTH SLIDES WERE INITIALLY ASPIRATED AND ANALYZED SUCCESSFULLY. WHEN MAKING THE SLIDE, THE AUTOSAMPLER INCORRECTLY DROPPED PATIENT A'S BLOOD ONTO A SLIDE THAT WAS LABELED IT WITH PATIENT'S B SID NUMBER. A MANUAL DIFFERENTIAL BLAST WAS PERFORMED ON THE MISLABELED SLIDE AND BLAST CELLS WERE DETECTED FROM THE SAMPLE. THE AFFECTED SLIDE WAS SENT TO A PATHOLOGIST FOR REVIEW AND THE PATHOLOGIST CONFIRMED THE PRESENCE OF 30% BLAST IN THE SAMPLE. THIS RESULT WAS REPORTED TO THE PHYSICIAN AND THE PHYSICIAN ORDERED A BONE MARROW BIOPSY FOR PATIENT B. PATIENT B UNDERWENT A BONE MARROW BIOPSY PROCEDURE. THE OPERATOR REMOVED SAMPLE B FROM THE ADVIA 2120I SYSTEM AND SENT THE SAMPLE TO A FLOW CYTOMETRY FOR CONFIRMATION. A NEGATIVE BLAST RESULT WAS OBTAINED FROM THE FLOW CYTOMETRY. SAMPLE B WAS RE-RUN ON AN ALTERNATE ADVIA 2120 HEMATOLOGY SYSTEM AND A NEW SMEAR WAS MADE. NO BLAST CELLS WERE DETECTED FROM THIS SAMPLE. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE MISLABELED SLIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6714977 ↗