Facility
IDS
2 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3015146106 |
|---|---|
| Establishment type | Repack or Relabel Medical Device |
| Location | 5425 Exploration Drive Indianapolis, IN, US 46241 |
| Registration status | Active · expires 2026 |
| Parent company | IDS (owner-operator 10062213) |
| Brand names | Digital Oral Thermometer |
Devices registered here (1)
- Clinical Electronic ThermometerProduct code SDV · Class II · General Hospital · 21 CFR 880.2910
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 2026-08-13. Verify this facility record at FDA →
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