Randox Liquid Clinical Chemistry Control Recalled for Transcription Error
Randox Laboratories is recalling Liquid Clinical Chemistry Control lot 1021 UE due to a transcription error in the Lipase value.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/transcription error rather than a physical defect or contamination.
Plain-English summary
Randox Laboratories Ltd. is recalling two units of Liquid Clinical Chemistry Control, Catalogue Number LAE4217, Size 12 x 5 ml. The specific lot affected is 1021 UE, with an expiration date of 2020-06-28.
The recall was initiated because of a transcription error in the Randox Lipase colorimetric value. The target and range were incorrectly listed as 50 U/L (40 - 60) on the product, whereas the correct values should be 72 U/L (58 - 86).
The product was distributed in New York and Delaware in the United States, as well as in France, Lithuania, Poland, Spain, Switzerland, Turkey, Australia, Hong Kong, Bosnia and Herzegovina, Costa Rica, Ecuador, Gambia, New Zealand, and the Solomon Islands. Users should stop using the affected lot and contact Randox Laboratories for further instructions.
The recalled product
- Product
- Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- Affected units
- 2
Distribution
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