Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Brand
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
Lot Codes / Batch Numbers
Catalogue Number: LAE4217 GTIN: 05055273208993 Lot Number: 1021UE (EXP: 2020-06-28)
Products Sold
Catalogue Number: LAE4217 GTIN: 05055273208993 Lot Number: 1021UE (EXP: 2020-06-28)
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland is recalling Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml due to A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range are. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range are listed as 50 U/L (40 - 60) and should be 72U/L (58 - 86).
Recommended Action
Per FDA guidance
On December 13, 2019 the firm distributed Urgent Medical Device Recall letters by e-mail stating: Urgent Medical Device Correction Complaint Reference: REC430 Action Type: Device Modification Our records indicate that your facility may have received the following product Detail on Affected Devices: Liquid Clinical Chemistry Control Catalogue Number: LAE4217 GTIN: 05055273208993 Lot Number: 1021UE Expiration Date: 30June2020 Manufacturing Date: 21Oct2018 Reason for Recall: A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range are listed as 50 U/L (40 - 60) and should be 72U/L (58 - 86). Risk to Health: Control falling out of range could lead to a delay in reporting patient results. See attached HHE. Action to be taken: - Update the affected kits with the correct target values provided. - 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. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organization. Please accept our apologies for any inconvenience caused. Thank you for your patience and understanding. If you have any questions or concern s, please contact Randox Technical Services.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
DE, NY
Page updated: Jan 10, 2026