BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYSIS MDM2/CEP 12 FISH PROBE KIT

    MDR report key: 18741277 · Received February 20, 2024

    Report

    Report Number
    3005248192-2024-00052
    Event Type
    Malfunction
    Date Received
    February 20, 2024
    Date of Event
    October 19, 2023
    Report Date
    February 20, 2024
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    OYU
    Removal / Correction Number
    3005248192-02/01/24-001-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H4 LEFT BLANK AS IT IS NOT AVAILABLE. ON JANUARY 23, 2024, A DECISION WAS MADE TO ISSUE A CUSTOMER LETTER. ON FEBRUARY 1, 2024, FA-AM-FEB2024-296 WAS ISSUED AS A FIELD CORRECTION RECALL TO NOTIFY CUSTOMERS THAT MULTIPLE PRODUCTS INTENDED FOR EXPORT ONLY, WHICH WERE NOT APPROVED OR REGISTERED FOR USE IN THE UNITED STATES (US), WERE SHIPPED TO US-BASED CUSTOMERS. FIELD ACTION WAS REPORTED PER 21 CFR 806 TO US FDA VIA 3005248192-02/01/24-001-R ON FEBRUARY 2, 2024, AND THEREFORE IS ALSO REPORTABLE UNDER 21 CFR 803. NO HAZARD IS ASSOCIATED WITH THIS ISSUE. LIST OF AFFECTED PRODUCTS: NAME: VYSIS MDM2 / CEP 12 FISH PROBE KIT, LIST NUMBER: 01N15-010, LOT NUMBER: 528081, EXPIRATION DATE: 16-NOV-2023, UDI: (B)(4); NAME: VYSIS MDM2 / CEP 12 FISH PROBE KIT, LIST NUMBER: 01N15-010, LOT NUMBER: 381146, EXPIRATION DATE: 05-MAY-2024, UDI: (B)(4); NAME: VYSIS MDM2 / CEP 12 FISH PROBE KIT, LIST NUMBER: 01N15-010, LOT NUMBER: 381870, EXPIRATION DATE: 05-MAY-2024, UDI: (B)(4); NAME: VYSIS MDM2 / CEP 12 FISH PROBE KIT, LIST NUMBER: 01N15-010, LOT NUMBER: 382179, EXPIRATION DATE: 05-MAY-2024, UDI: (B)(4); NAME: VYSIS MDM2 / CEP 12 FISH PROBE KIT, LIST NUMBER: 01N15-010, LOT NUMBER: 387021, EXPIRATION DATE: 01-AUG-2024, UDI: (B)(4); NAME: VYSIS LSI ATM (11Q22.3) SPECTRUMORANGE PROBE, LIST NUMBER: 01N33-020, LOT NUMBER: 381411, EXPIRATION DATE: 22-SEP-2024, UDI: (B)(4); NAME: VYSIS LSI D13S319 (13Q14.3) SPECTRUMORANGE PROBE, LIST NUMBER: 01N34-020, LOT NUMBER: 522756, EXPIRATION DATE: 21-JUN-2023, UDI: (B)(4); NAME: M1000 INSTRUMENT WASH STATION, LIST NUMBER: 04J72-28, LOT NUMBER: N/A, EXPIRATION DATE: N/A UDI: (B)(4); NAME: VYSIS PTEN/CEP 10 FISH PROBE KIT, LIST NUMBER: 04N62-020, LOT NUMBER: 382133, EXPIRATION DATE: 25-MAY-2024, UDI: (B)(4); NAME: VYSIS TELVYSION 1P SPECTRUMGREEN PROBE 5L, LIST NUMBER: 05J03-001, LOT NUMBER: 381111, EXPIRATION DATE: 17-JUN- 2024, UDI: (B)(4); NAME: VYSIS TELVYSION 4P SPECTRUMGREEN PROBE 5L, LIST NUMBER: 05J03-004, LOT NUMBER: 381102, EXPIRATION DATE: 17-JUN-2024, UDI: (B)(4); NAME: VYSIS TELVYSION 22Q SPECTRUMORANGE PROBE 5L, LIST NUMBER: 05J04-022, LOT NUMBER: 530242, EXPIRATION DATE: 28-MAR-2024, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS IDENTIFIED THAT DURING THE MIGRATION OF THE ABBOTT MOLECULAR DIAGNOSTICS (MDX) AVANTE ERP SYSTEM INTO SAP SYMPHONY, THE LEGAL CONTROL SETTING FOR LIST NUMBER 01N15-010 (01N1510) FOR US PLANTS WAS INCORRECTLY SET TO ALLOW US DISTRIBUTION. THIS PRODUCT IS LABELED AS CE-MARKED (CONFORMITE EUROPEENNE) AND IS NOT INTENDED FOR US DISTRIBUTION. PER INVESTIGATION, THE PRODUCTS IDENTIFIED AS NONCONFORMING ARE LISTED IN H11. NO RESULTS WOULD HAVE BEEN IMPACTED AS A RESULT OF USING THE CE-MARKED PART. A COMPARISON WAS CONDUCTED BETWEEN THE CE MARKED OR ANALYTE SPECIFIC REAGENT (ASR) PRODUCTS SHIPPED AND THE SIMILAR US PRODUCT. AS THE SIMILAR US PRODUCTS HYBRIDIZE IN THE SAME REGION, THE FUNCTION WOULD BE THE SAME OF THE AFFECTED PRODUCTS. LIST 01N15-010 CONTAINS PERFORMANCE CLAIMS IN ITS ASSOCIATED PACKAGE INSERT WHICH ARE NOT APPLICABLE TO THE US MARKET AS THE PRODUCT WAS NOT INTENDED FOR DISTRIBUTION TO THE US. ALL OTHER AFFECTED PRODUCTS ONLY CONTAIN ANALYTE SPECIFIC REAGENT (ASR) INFORMATION AND DO NOT CONTAIN ANY PERFORMANCE CLAIMS. ALL PRODUCTS SHIPPED WERE APPROVED FOR RELEASE IN THEIR INTENDED MARKETS AND WERE WITHIN THEIR EXPIRATION DATING. THERE IS NO HAZARD ASSOCIATED WITH THESE PRODUCTS HOWEVER, THERE IS REGULATORY IMPACT AS THE PRODUCTS HAVE NOT BEEN APPROVED FOR RELEASE IN THE US MARKET. FIELD ACTION FA-AM-FEB2024-296, WAS TAKEN TO ADDRESS THIS ISSUE. IT WAS DEEMED REPORTABLE PER 21CFR806 AND THEREFORE WILL BE REPORTED UNDER 21CFR803.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088304 VYSIS MDM2/CEP 12 FISH PROBE KIT DNA-PROBE KIT, HUMAN CHROMOSOME OYU ABBOTT MOLECULAR, INC. 528081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown