VysisRecalls & reported problems across all models

We found 9 models of Vysis by Abbott Molecular Inc. in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, received between Aug 10, 2016 and Mar 27, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (4 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Vysis recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 4, 2021Terminated

   Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.

   Z-2576-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Vysis problems

Vysis models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Vysis 04N02-021

  Fluorescence in situ hybridization, chromosome 17p deletion (TP53)
  1 recall1 report
• Vysis 06N38-010

  Dna-probe kit, human chromosome
  2 reports
• Vysis 05J38-010

  Dna-probe kit, human chromosome
  1 report
• Vysis 05J38-050

  Dna-probe kit, human chromosome
  1 report
• Vysis 05J70-001

  REAGENTS,SPECIFIC,ANALYTE
  1 report
• Vysis 05J82-001

  REAGENTS,SPECIFIC,ANALYTE
  1 report
• Vysis 06J96-001

  REAGENTS,SPECIFIC,ANALYTE
  1 report
• Vysis 06N38-005

  Dna-probe kit, human chromosome
  1 report
• Vysis 06N38-033

  Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
  1 report

Recent Vysis adverse event reports

The 10 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT THERE WAS A DISCREPANT PATIENT RESULT REPORTED AFTER TESTING WITH THE VYSIS LSI BCR/ABL, DUAL COLOR, DUAL FUSION TRANSLOCATION PROBE SET, LIST NUMBER (LN) 05J82-01, LOT 399485. SID (B)(6) RESULT WAS INTERPRETED AS A DELETION AND NOT A FUSION; 1R2G1F INSTEAD OF 1R1G2F ON (B)(6)2024. THIS WAS A DIAGNOSTIC SPECIMEN AND THE CUSTOMER IDENTIFIED THE ABNORMALITY WHEN THEY RECEIVED A BONE MARROW FOR THIS PATIENT THAT WAS CONFIRMED POSITIVE FOR BCR: ABL1 FUSION ON (B)(6)2025. THE CUSTOMER THEN WENT BACK AND REHYBRIDIZED WITH A NEW LOT AND IDENTIFIED THE FUSION (1R1G1F VARIANT PATTERN). THE REPORT WAS REVISED ON (B)(6)2025. THE CML TREATMENT FOR THE PATIENT WAS DELAYED FROM (B)(6)2024 TO (B)(6) 2025. THE VYSIS LSI BCR/ABL DUAL COLOR DUAL FUSION PROBES (LIST 05J82-001) IS AN ANALYTE SPECIFIC REAGENT (ASR). ANALYTICAL AND PERFORMANCE CHARACTERISTICS ARE NOT ESTABLISHED. THE CUSTOMER USED THE VYSIS LSI BCR/ABL DUAL COLOR DUAL FUSION PROBES (LIST 05J82-001) ASR IN THEIR LABORATORY DEVELOPED TEST (LDT). THE LDT TEST WAS DEVELOPED, AND ITS ANALYTICAL PERFORMANCE CHARACTERISTICS WERE DETERMINED BY THE CUSTOMER. IT HAS NOT BEEN CLEARED OR APPROVED BY THE US FOOD AND DRUG A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21709732 ↗
• MalfunctionMar 26, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  THE CUSTOMER REPORTED RECEIVING ONE BROKEN SLIDE IN THEIR ORDER OF CGH TARGET SLIDES NORMAL METAPHASE SLIDES. THE CUSTOMER WAS WEARING LATEX GLOVES AND NO ONE WAS INJURED. THE SLIDES WERE REPLACED WITH A NEW LOT. THERE WAS NO PATIENT INVOLVED AS THE BROKEN SLIDE WAS IDENTIFIED BY THE USER PRIOR TO USAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21701044 ↗
• MalfunctionAug 27, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT ON THE VYSIS ALK BREAK APART FISH. THE CUSTOMER TESTED A SAMPLE AND FOUND THAT IMMUNOHISTOCHEMISTRY (IHC) RESULTS AND PCR RESULTS WERE 90% POSITIVE, BUT THE FISH RESULTS WERE LESS THAN 5%. THE VYSIS ALK BREAK APART FISH'S MANUFACTURE DATE WAS MAY 2023 AND EXPIRATION DATE WAS APRIL 2024. THE KIT WAS EXPIRED AT THE TIME OF THE REPORTED EVENT. THE CUSTOMER REPORTED THAT THEY CAN SEE ALL FUSION SIGNAL AND DID NOT BELIEVE THE EXPIRED KIT WOULD CAUSE DIFFERENT RESULTS BETWEEN THE IHC AND PCR. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT. THE NEGATIVE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076816 ↗
• MalfunctionAug 21, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  THE CUSTOMER REPORTED RECEIPT OF A BROKEN SLIDE OF PROBECHEK ALK NEGATIVE CONTROL SLIDES II. THERE WAS NO INJURY OR IMPACT AS A RESULT OF THE BROKEN SLIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20020979 ↗
• MalfunctionDec 22, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A SAMPLE WITH AN ABNORMAL SIGNAL WHEN USING ANEUVYSION DNA PROBE KIT. THE CUSTOMER REPORTED ON (B)(6) 2023 THAT THE CEP-Y SIGNAL IS SMALL AND HAS REGULAR DOTS. ON (B)(6) 2023, THE CUSTOMER PERFORMED KARYOTYPE ANALYSIS AND A DNA MICROARRAY WHICH GAVE A RESULT OF Y-CHROMOSOME NORMAL. THE ABNORMAL Y CHROMOSOME RESULT WAS COMMUNICATED TO THE PATIENT. THERE HAS BEEN NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383280 ↗
• InjuryJun 14, 2022False Positive Result; Off-Label Use; False Positive Result; Off-Label Use

  ON (B)(6) 2022, THE FDA FORWARDED MEDWATCH FORM MW5109350 TO ABBOTT MOLECULAR. A PATIENT FILED A REPORT WITH THE FDA ON (B)(6) 2022, FOR AN OTHER SERIOUS OR IMPORTANT MEDICAL EVENT THAT OCCURRED ON (B)(6) 2022. THE DESCRIPTION OF THE EVENT STATES: I HAD A POSITIVE SCREEN ON MY NIPT (NONINVASIVE PRENATAL TESTING) FOR TRISOMY 21. CHOSE TO DO INVASIVE TESTING, WHICH PROVED TO BE INACCURATE. IT IS UNKNOWN WHAT SAMPLE TYPE WAS USED, HOW THE PROTOCOL WAS CARRIED OUT, HOW THE RESULT WAS REPORTED, AND WHEN AMNIOCENTESIS WAS ORDERED. THE IMPACT ON PATIENT MANAGEMENT IS NOT KNOWN. THE AGENCY DID NOT PROVIDE THE NAME OF THE TESTING FACILITY WHERE THE TEST WAS CARRIED OUT. THE SPECIFIC PRODUCT NAME USED IN THE TEST WAS NOT PROVIDED EITHER. HOWEVER, THE FORM LISTS THE BRAND NAME AS NIPT AND THE MANUFACTURER AS ABBOTT MOLECULAR. THE ANEUVYSION MULTICOLOR DNA PROBE KIT IS NOT A NIPT OR NIPS (NONINVASIVE PRENATAL SCREENING). NONINVASIVE PRENATAL TESTING (NIPT), SOMETIMES CALLED NONINVASIVE PRENATAL SCREENING (NIPS), IS A METHOD OF DETERMINING THE RISK THAT THE FETUS WILL BE BORN WITH CERTAIN GENETIC ABNORMALITIES. THIS TESTING ANALYZES SMALL FRAGMENTS OF DNA THAT ARE CIRCULATING IN A PREGNANT WOMA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14690649 ↗
• MalfunctionAug 26, 2021False Negative Result; False Negative Result

  CUSTOMER REPORTED CONCERN DUE TO HAVING TESTED PATIENT SAMPLES WITH CLL FISH PROBE KIT LOT, 518656 AND 517068. ON JULY 27TH, THE CUSTOMER EXPRESSED CONCERN TO THEIR AMBASSADOR AFTER READING A POST PUBLISHED BY (B)(6) UNIVERSITY. CUSTOMER LATER RECEIVED FA-AM-AUG2021-258A (TICKET (B)(4)), WHICH ACKNOWLEDGES THAT VYSIS CLL FISH PROBE KIT, LIST 04N02-021 LOTS 517086 AND 518656 HAVE BEEN LINKED TO REPORTS OF THE VYSIS CLL FISH PROBE KITS NOT DETECTING 13Q DELETIONS IN KNOWN POSITIVE PATIENT SAMPLES. NEW LOT OF CLL FISH PROBE WAS SHIPPED TO CUSTOMER AND PREVIOUSLY RELEASED NEGATIVE PATIENT SAMPLES ARE TO BE VERIFIED WITH THE NEW LOT. TICKET WAS MARKED AS POTENTIAL REPORTABLE EVENT (PRE) DUE TO POTENTIAL IMPACT ONCE PATIENT SAMPLES ARE RE-TESTED. AT THIS TIME NUMBER OF PATIENT SAMPLES POSSIBLY AFFECTED IS NOT KNOWN. IMPACT TO PATIENT MANAGEMENT IS NOT KNOWN. CUSTOMER FOLLOW UP INDICATES THAT PATIENT RE-TESTING HAS NOT TAKEN PLACE DUE TO SHORTAGE OF REAGENT SUPPLY. CUSTOMER WILL BE OUT OF OFFICE WEEK OF AUG 23RD. AT THIS TIME, THERE IS NO ALLEGATION OF DISCREPANT RESULTS, HOWEVER THIS EVALUATION WILL BE PROCESSED AS A WORST CASE FALSE NEGATIVE RESULT ON CLL PROBE, 4N02-21, WHICH IS ASSOCI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12375637 ↗
• MalfunctionJun 21, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  THE CUSTOMER REPORTED THAT THE ABBOTT MOLECULAR FISH VYSIS PROBE VIAL ARRIVED CRUSHED INSIDE THE SHIPPING BOX, AND THE PRODUCT WAS NOT USABLE. THE OUTER SHIPPING BOX WAS INTACT, AND NO OUTSIDE BOX DAMAGE WAS OBSERVED. THE PROBE PACKAGING WAS INTACT, AND THERE WAS A LARGE PIECE OF ICE ON TOP OF THE PACKAGE. THE BROKEN VIAL WAS INSIDE THE PACKAGE. THE CUSTOMER USED PPE (PERSONAL PROTECTIVE EQUIPMENT) WHEN OPENING THE SHIPMENT. THERE WAS NO INJURY CAUSED BY THE BROKEN PLASTIC PROBE VIAL.

  Patient problems: No Patient Involvement

  MAUDE report 8724041 ↗
• MalfunctionFeb 26, 2018Device Damaged Prior to Use; Device Damaged Prior to Use

  THE PROBECHEK ALK POSITIVE CONTROL SLIDES ARE INTENDED FOR USE AS AN ASSAY CONTROL FOR APPROPRIATE HYBRIDIZATION CONDITIONS DURING ROUTINE USE OF THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38). THE PROBECHEK ALK POSITIVE CONTROL SLIDES SHOULD BE ASSAYED IN CONJUNCTION WITH THE USER'S SPECIMEN SLIDES ACCORDING TO THE PACKAGE INSERT FOR THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38). CUSTOMER REPORTED THAT WHEN OPENING ALK POSITIVE CONTROL SLIDES ONE SLIDE WAS BROKEN. THE CUSTOMER DID NOT REPORT ANY INJURY. LAB TECHNICIAN WAS WEARING PROTECTIVE EQUIPMENT. THE OUTER BOX APPEARED TO BE SLIGHTLY RECESSED LIKE PRESSURE HAD BEEN PUT ON IT. THE PROBECHEK ALK POSITIVE CONTROL SLIDE PACKAGE INSERT INDICATES THESE SLIDES CONTAIN HUMAN SOURCED AND/OR INFECTIOUS COMPONENTS. IF THIS EVENT WERE TO RECUR, IT IS POSSIBLE CUSTOMERS COULD CUT THEMSELVES WITH A POTENTIALLY INFECTIOUS SLIDE. THERE IS NO PATIENT INVOLVED AS THE BROKEN SLIDE WAS OBSERVED DURING OPENING OF THE PRODUCT BY A LABORATORY TECHNICIAN.

  Patient problems: No Patient Involvement

  MAUDE report 7298180 ↗
• MalfunctionAug 10, 2016Device Damaged Prior to Use; Device Damaged Prior to Use

  THE PROBECHEK ALK POSITIVE CONTROL SLIDES ARE INTENDED FOR USE AS AN ASSAY CONTROL FOR APPROPRIATE HYBRIDIZATION CONDITIONS DURING ROUTINE USE OF THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38). THE PROBECHEK ALK POSITIVE CONTROL SLIDES SHOULD BE ASSAYED IN CONJUNCTION WITH THE USER'S SPECIMEN SLIDES ACCORDING TO THE PACKAGE INSERT FOR THE VYSIS ALK BREAK FISH PROBE KIT. A CUSTOMER REPORTED THAT 2 OUT OF 5 PROBECHEK ALK POSITIVE CONTROL SLIDES WERE RECEIVED BROKEN. THERE WAS NO REPORT OF INJURY. THE PROBECHECK ALK POSITIVE CONTROL SLIDE PACKAGE INSERT INDICATES THESE SLIDES CONTAIN HUMAN SOURCED AND/OR POTENTIALLY INFECTIOUS COMPONENTS. IF THIS EVENT WERE TO RECUR, IT IS POSSIBLE CUSTOMERS COULD CUT THEMSELVES WITH A POTENTIALLY INFECTIOUS SLIDE.

  Patient problems: No Patient Involvement

  MAUDE report 5864091 ↗

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