Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that
FDA device recall Z-1328-2024 · posted 2024-03-20 · Open, Classified
Recall details
- Recalling firm
- Randox Laboratories Ltd.
- Reason for recall
- The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
- Action taken
- Consignees were sent a MEDICAL DEVICE CORRECTION NOTIFICATION dated 03/06/2024. The notification instructs consignees to review results generated with the affected batches in line with the clinical profile of the patient, discuss the contents of the provided recall notice with the facility's Medical Director, and complete and return the response form to technical.services@randox.com within five working days. The notice should be shared with all customers if product was further distributed and to those who need to be aware within consignee organizations. Consignees with questions should reach out to Randox Technical Services.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JIX
- Quantity affected
- 1,764 units
- Distribution
- Domestic: CA, FL, IL, ME, NJ, OH, & OR.
- Date initiated
- 2024-03-01
- Date posted
- 2024-03-20
- Location
- Crumlin, North, Ireland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RANDOX LIQUID PROTEIN CALIBRATOR (K061056) | Randox Laboratories, Ltd. | 2006-07-20 |