FDA Medical devices recall · December 4, 2024

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

Read the official FDA notice ↗

Product

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

Why was it recalled?

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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

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, L

Distribution

Worldwide - US Nationwide distribution in the states of MS, AR, TX, CA, MA, MI, FL, OK, WI, IN, MN, OH, NJ, NY, IL, KY, NV, HI, SD, ID, MI, UT, WA, MO, VA, GA and the countries of DE, CN, JP, UY.

States: Arkansas California Delaware Florida Georgia Hawaii Idaho Illinois Indiana Kentucky Massachusetts Michigan Minnesota Missouri Mississippi New Jersey Nevada New York Ohio Oklahoma South Dakota Texas Utah Virginia Washington Wisconsin

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0553-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.