IgE Calibrator Series
FDA device recall Z-0050-2017 · posted 2016-10-06 · Terminated
Recall details
- Recalling firm
- Randox Laboratories Ltd.
- Reason for recall
- According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned to the 3rd International Standard for human serum IgE 11/234. Turbidimetric (Non-IFCC Cal.) Quality Control Targets and Ranges now apply. The calibrator value sheet is to be updated with the new values.
- Action taken
- The firm plans on contacting each consignee about the recall.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- DGC
- Quantity affected
- 4
- Distribution
- All consignees are in the US.
- Date initiated
- 2016-09-07
- Date posted
- 2016-10-06
- Date terminated
- 2017-09-07
- Location
- Crumlin, North, Ireland
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RANDOX IGE (K010855) | Randox Laboratories, Ltd. | 2001-05-15 |