Iso-Tex Diagnostics, Inc
Iso-Tex Diagnostics, Inc appears in FDA public data with 2 recalls, 3 510(k) clearances, 12 FDA inspections, and 3 compliance actions on record. Its most recent recall (D-1136-2019, Class II) was initiated on April 15, 2019. Its most recent 510(k) clearance was granted on July 10, 1985.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 3
- Inspections
- 12
- Compliance Actions
- 3
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-1136-2019 | Class II | Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for | April 15, 2019 |
| D-1008-2019 | Class II | Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for | March 11, 2019 |