Z-1100-2020 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2020
- Initiation Date
- December 13, 2019
- Termination Date
- October 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
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).
Distribution Pattern
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.
Code Information
Catalogue Number: LAE4217 GTIN: 05055273208993 Lot Number: 1021UE (EXP: 2020-06-28)