Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Reported: February 12, 2020 Initiated: December 13, 2019 #Z-1100-2020
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).
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 2
- 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.
- Location
- Crumlin (North), N/A
Frequently Asked Questions
What product was recalled? ▼
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml. Recalled by Randox Laboratories Ltd.. Units affected: 2.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2020. Severity: Low. Recall number: Z-1100-2020.
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