Recall record at a glance
| Official record | Z-0553-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Shimadzu Corp. Analytical & Measuring Instruments Div. |
| Report date | Dec 4, 2024 |
| Recall initiation date | Oct 9, 2024 |
| Quantity | 179 |
| Location | Kyoto, Japan |
Official product description
Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL
Why the product was 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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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