FDA Medical Device Recalls (openFDA)
Randox Laboratories, Limited: Assayed Bovine Multi-Sera Level 1, Model No. AL1027
- Recall number
- Z-2207-2019
- Recalling firm
- Randox Laboratories, Limited
- Product
- Assayed Bovine Multi-Sera Level 1, Model No. AL1027
- Status
- Terminated
- Initiated
- 2019-06-10
- Posted
- not on file
- Terminated
- 2020-06-16
- Reason
- The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.
- Root cause
- Process design
- Action
- On June 7, 2019, the firm notified customers of the recall by issuing an Urgent Medical Device Correction letter. Customers were asked to take the following actions: * Inspect your stock and quarantine affected stock on hand to prevent further use. " Discard all value sheets and replace these with the value :sheets provided. " A review of previously generated patient results is not required as control failure is evident at the time of testing. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. *Send a copy of the FSN to all affected customers and to those who need to be aware within your organization. If you have any questions or concerns, please contact Rand ox Technical Services.
- Quantity
- 4 kits (US)
- Distribution
- Domestic distribution to Arizona, Oregon, Washington, and West Virginia. Foreign distribution to Australia, Belarus, Canada, France, Germany, Ireland, Kenya, Korea, Lithuania, New Zealand, Nigeria, Oman, Russia, Singapore, South Africa, Sweden, Switzerland, Turkey, and UK.
- Lot, serial or model codes
- 205SL
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJY
- Firm FEI
- 1000361607
- Firm city
- Crumlin
- Firm state
- not on file
- Firm country
- United Kingdom
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