FDA Medical Device Recalls (openFDA)
RANDOX LABORATORIES, LTD.: Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
- Recall number
- Z-2753-2020
- Recalling firm
- RANDOX LABORATORIES, LTD.
- Product
- Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
- Status
- Terminated
- Initiated
- 2020-06-26
- Posted
- 2020-08-04
- Terminated
- 2020-10-19
- Reason
- Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.
- Root cause
- Unknown/Undetermined by firm
- Action
- Randox sent an urgent medical device correction notification dated June 22, 2020 explaining the current failure with select lots of Lipase Colorimetric products. The firm advised customers to scrap all effected product, keep proof of destruction, review replacements needs, review results of patients generated using affected batches and return the firm's response card.
- Quantity
- not on file
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.
- Lot, serial or model codes
- Catalogue Numbers: LI015/000/UL, LI015/003/UL, LI015/000/UL Lot #: 1049LI, 1051LI
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CHI
- Firm FEI
- 3006697287
- Firm city
- Crumlin Antrim
- Firm state
- Colorado
- 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