Facility
IDS CO, LTD
2 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3005655287 |
|---|---|
| Establishment type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | 8-14-30 Kumamoto-Shi, JP 86180 |
| Registration status | Active · expires 2026 |
| Parent company | IDS CO, LTD (owner-operator 10049986) |
| Brand names | Power Express |
Devices registered here (5)
- Radioimmunoassay, Thyroid-Stimulating HormoneProduct code JLW · Class II · Clinical Chemistry · 21 CFR 862.1690
- Acid, Folic, RadioimmunoassayProduct code CGN · Class II · Clinical Chemistry · 21 CFR 862.1295
- Radioassay, Vitamin B12Product code CDD · Class II · Clinical Chemistry · 21 CFR 862.1810
- Analyzer, Chemistry (Photometric, Discrete), For Clinical UseProduct code JJE · Class I · Clinical Chemistry · 21 CFR 862.2160
- Ferritin, Antigen, Antiserum, ControlProduct code DBF · Class II · Immunology · 21 CFR 866.5340
Recalls & enforcement
- Class IIOngoing2024-10-16The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
- Class IITerminated2012-11-07Immunodiagnostic Systems is recalling the 25-Hydroxy Vitamin D EIA, AC-57F1 because the QC report was found to have an erroneous calibrator value assigned. The value of 24.4 ng/mL for calibrator 4 was stated on the QC report, however the correct value should have read 28.4 ng/mL
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-15. Verify this facility record at FDA →
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