Randox Bovine Multi-Sera Control Lot Recall for Bile Acids Target Adjustment
Randox Laboratories is recalling Assayed Bovine Multi-Sera Level 1 Control Lot 205SL to re-assign the Mean of all Instruments target and range for Bile Acids.
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 is defined as unlikely to cause adverse health consequences, and involves a documentation/specification adjustment rather than a physical hazard.
Plain-English summary
Randox Laboratories, Limited is recalling Assayed Bovine Multi-Sera Level 1, Model No. AL1027, Control Lot 205SL. The recall involves 4 kits distributed in the United States and internationally.
The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in this control lot. This action is taken to ensure the accuracy of the product's specifications.
The product was distributed domestically to Arizona, Oregon, Washington, and West Virginia. It was also distributed to Australia, Belarus, Canada, France, Germany, Ireland, Kenya, Korea, Lithuania, New Zealand, Nigeria, Oman, Russia, Singapore, South Africa, Sweden, Switzerland, Turkey, and the UK. Users should contact Randox Laboratories for further instructions.
The recalled product
- Product
- Assayed Bovine Multi-Sera Level 1, Model No. AL1027
- Manufacturer
- Randox Laboratories, Limited
- Hazard
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 205SL
Distribution
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