FDA Medical Device Recalls (openFDA)
Randox Laboratories Ltd.: IgE Calibrator Series
- Recall number
- Z-0050-2017
- Recalling firm
- Randox Laboratories Ltd.
- Product
- IgE Calibrator Series
- Status
- Terminated
- Initiated
- 2016-09-07
- Posted
- 2016-10-06
- Terminated
- 2017-09-07
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- The firm plans on contacting each consignee about the recall.
- Quantity
- 4
- Distribution
- All consignees are in the US.
- Lot, serial or model codes
- Catalogue number IE2492 Batch number 354213, 386994
- 510(k) numbers
- ["K010855"]
- PMA numbers
- not on file
- Product code
- DGC
- Firm FEI
- 1000361607
- Firm city
- Crumlin
- Firm state
- North
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28