FDA Enforcement
Class III
Terminated
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Recall: Z-1100-2020
·
Reported February 12, 2020
Enforcement
- Recall Number
- Z-1100-2020
- Event ID
- 84547
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Randox Laboratories Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 12, 2020
- Initiation Date
- December 13, 2019
- Classification Date
- February 6, 2020
- Termination Date
- October 2, 2020
- Address
- 55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland
Description
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Reason
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).
Code Info
Catalogue Number: LAE4217 GTIN: 05055273208993 Lot Number: 1021UE (EXP: 2020-06-28)
Distribution
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.
Quantity
2