Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Recall
- Recall Number
- Z-1100-2020
- Event Number
- 84547
- Firm
- Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
- FEI Number
- 1000361607
- Product Code
- JJY
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- December 13, 2019
- Terminated
- October 2, 2020
Description
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
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).
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 [email protected] 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.
US: NY and DE OUS: France, Lithuania, Poland, Spain, Switzerland, Turkey, Australia, Hong Kong, Bosnia and Herzegovina, Costa Rica, Ecuador, Gambia, New Zealand and Solomon Islands.
2