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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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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