Immunodiagnostics Systems Ltd
FDA Regulatory Profile
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 0
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0042-2013 | Class II | IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bo | August 10, 2012 |
| Z-0039-2013 | Class II | IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing | August 10, 2012 |
| Z-0045-2013 | Class II | IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plast | August 10, 2012 |
| Z-0044-2013 | Class II | IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. | August 10, 2012 |
| Z-0040-2013 | Class II | IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box | August 10, 2012 |
| Z-0043-2013 | Class II | IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bo | August 10, 2012 |
| Z-0041-2013 | Class II | IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in ca | August 10, 2012 |