Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 c
FDA device recall Z-1759-2024 · posted 2024-05-03 · Open, Classified
Recall details
- Recalling firm
- Randox Laboratories Ltd.
- Reason for recall
- Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
- Action taken
- Consignees were emailed a Medical Device Correction notice dated 3/5/2024 instructing them to discuss the contents of the notification with their facility's Medical Director if affected units have been used, replace the IFU for affected devices with the one provided with the notification, and complete and return the provided response form by email to technical services@randox.com within five working days. Updated IFUs can be accessed at www.randox.com and questions can be directed to technical.services@randox.com.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- JIX
- Quantity affected
- 80,366 units (US: 242 units; OUS: 80,094 units)
- Distribution
- Domestic: Nationwide Distribution.
- Date initiated
- 2024-03-05
- Date posted
- 2024-05-03
- Location
- Crumlin, North, Ireland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RANDOX CALIBRATION SERUM (K053153) | Randox Laboratories, Ltd. | 2006-01-13 |