🔍 RecallPedia

Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL

Class I - Dangerous
🏥 Medical Devices Recalled: October 9, 2024 Shimadzu Corp. Analytical & Measuring Instruments Div. Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model/UDI-DI/Serial Number: SIL-20ACXR CL/04540217420131/L20995250001, L20995250002, L20995250003, L20995250004, L20995250005, L20995250006, L20995250007, L20995250008, L20995350010, L20995350011, L20995350012, L20995350013, L20995350014, L20995350015, L20995450016, L20995450017, L20995450018, L20995450019, L20995450020, L20995450021, L20995450022, L20995450023, L20995450024, L20995450025, L20995450026, L20995550027, L20995550028, L20995550029, L20995550030, L20995650031, L20995650032, L20995650033, L20995650034, L20995650035, L20995650036, L20995650037, L20995650038, L20995650039, L20995650040, L20995650041, L20995650042, L20995650043, L20995650044, L20995650045, L20995650046, L20995560001, L20995660002, L20995660003, L20995660004, L20995660005, L20995660006, L20995660007, L20995660008, L20995660009, L20995660010, L20995660011, L20995660012, L20995660013, L20995660014, L20995660015, L20995660016, L20995660017, L20995660018, L20995660019, L20995660020, L20995660021, L20995660022, L20995660023, L20995660024, L20995660025, L20995660026, L20995660027, L20995660028, L20995660029, L20995660030, L20995660031, L20995660032, L20995660033, L20995660034, L20995660035, L20995660036, L20995660037, L20995660038, L20995660039, L20995660040, L20995660041, L20995660042, L20995660043, L20995660044, L20995660045, L20995660046, L20995660047, L20995660048, L20995660049, L20995660050, L20995660051, L20995660052, L20995660053, L20995660054, L20995660055, L20995660056, L20995660057, L20995250009, L20995270001, L20995270002, L20995270003, L20995270004, L20995270005, L20995370006, L20995370007, L20995370008, L20995370009, L20995370010, L20995370011, L20995370012, L20995370013, L20995370014, L20995370015, L20995370016, L20995370017, L20995370018, L20995370019, L20995370020, L20995370021, L20995370022, L20995370023, L20995370024, L20995370025, L20995470028, L20995770032. SIL-20ACHT CL/04540217420124/L20985350001, L20985450002, L20985750003, L20985750004. SIL-30AC CL/04540217420155/L21005250001, L21005250002, L21005250003, L21005250004, L21005250005, L21005250006, L21005250007, L21005350008, L21005350009, L21005350010, L21005350011, L21005350012, L21005350013, L21005350014, L21005350015, L21005350016, L21005350017, L21005350018, L21005350019, L21005350020, L21005350021, L21005350022, L21005350023, L21005350024, L21005450025, L21005550026, L21005550027, L21005650028, L21005650029, L21005750030, L21005750031, L21005570001, L21005570002, L21005670003, L21005670004, L21005670005, L21005670006, L21005670007, L21005670008, L21005770009, L21005770010, L21005770011, L21005770012, L21005770013, L21005770014.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Shimadzu Corp. Analytical & Measuring Instruments Div.
Reason for Recall:
There have been cases of failure of the main board due to condensation water drained from the Peltier dehumidifier, leaked out from the tray, resulting in a short circuit. In the serious case, the main board and adjacent cables are partly charred. In the minor case, the Y motor and its surrounding die cast part become rusty. These failures could result in delay in patient sample testing.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL

Product Codes/Lot Numbers:

Model/UDI-DI/Serial Number: SIL-20ACXR CL/04540217420131/L20995250001, L20995250002, L20995250003, L20995250004, L20995250005, L20995250006, L20995250007, L20995250008, L20995350010, L20995350011, L20995350012, L20995350013, L20995350014, L20995350015, L20995450016, L20995450017, L20995450018, L20995450019, L20995450020, L20995450021, L20995450022, L20995450023, L20995450024, L20995450025, L20995450026, L20995550027, L20995550028, L20995550029, L20995550030, L20995650031, L20995650032, L20995650033, L20995650034, L20995650035, L20995650036, L20995650037, L20995650038, L20995650039, L20995650040, L20995650041, L20995650042, L20995650043, L20995650044, L20995650045, L20995650046, L20995560001, L20995660002, L20995660003, L20995660004, L20995660005, L20995660006, L20995660007, L20995660008, L20995660009, L20995660010, L20995660011, L20995660012, L20995660013, L20995660014, L20995660015, L20995660016, L20995660017, L20995660018, L20995660019, L20995660020, L20995660021, L20995660022, L20995660023, L20995660024, L20995660025, L20995660026, L20995660027, L20995660028, L20995660029, L20995660030, L20995660031, L20995660032, L20995660033, L20995660034, L20995660035, L20995660036, L20995660037, L20995660038, L20995660039, L20995660040, L20995660041, L20995660042, L20995660043, L20995660044, L20995660045, L20995660046, L20995660047, L20995660048, L20995660049, L20995660050, L20995660051, L20995660052, L20995660053, L20995660054, L20995660055, L20995660056, L20995660057, L20995250009, L20995270001, L20995270002, L20995270003, L20995270004, L20995270005, L20995370006, L20995370007, L20995370008, L20995370009, L20995370010, L20995370011, L20995370012, L20995370013, L20995370014, L20995370015, L20995370016, L20995370017, L20995370018, L20995370019, L20995370020, L20995370021, L20995370022, L20995370023, L20995370024, L20995370025, L20995470028, L20995770032. SIL-20ACHT CL/04540217420124/L20985350001, L20985450002, L20985750003, L20985750004. SIL-30AC CL/04540217420155/L21005250001, L21005250002, L21005250003, L21005250004, L21005250005, L21005250006, L21005250007, L21005350008, L21005350009, L21005350010, L21005350011, L21005350012, L21005350013, L21005350014, L21005350015, L21005350016, L21005350017, L21005350018, L21005350019, L21005350020, L21005350021, L21005350022, L21005350023, L21005350024, L21005450025, L21005550026, L21005550027, L21005650028, L21005650029, L21005750030, L21005750031, L21005570001, L21005570002, L21005670003, L21005670004, L21005670005, L21005670006, L21005670007, L21005670008, L21005770009, L21005770010, L21005770011, L21005770012, L21005770013, L21005770014.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0553-2025

Related Recalls

Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL

Shimadzu Corp. Analytical & Measuring Instruments Div.

Class I - Dangerous

There have been cases of failure of the main board due to condensation water occurring in the gap between thermal insulation material on the underside of the main base dropping onto the main board The symptoms and errors differ depending on the position where the water drops adhere. To date there have been examples of reports of inter-board communication errors, HOME POSITION error or SLIP error of XYZ drive units. The failure could result in delay of patient sample testing.

Oct 9, 2024 Other Medical Devices Nationwide View Details →