Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Check against the official notice below — it lists the full affected range.
Randox Laboratories Ltd. is recalling Liquid Clinical Chemistry Control (catalogue number LAE4217, lot 1021UE) due to a transcription error on the product labeling. The correct target and range for the Lipase colorimetric value should be 72 U/L (58-86), but the label incorrectly states 50 U/L (40-60). Two units of this product were distributed to locations in the United States (New York and Delaware) as well as multiple international locations including France, Lithuania, Poland, Spain, Switzerland, Turkey, Australia, Hong Kong, Bosnia and Herzegovina, Costa Rica, Ecuador, Gambia, New Zealand, and Solomon Islands.
The product in question has lot number 1021UE with an expiration date of June 28, 2020. The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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).
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: 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 Lot/code info: Catalogue Number: LAE4217 GTIN: 05055273208993 Lot Number: 1021UE (EXP: 2020-06-28)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.