Randox Calibration Serum Recalled for Incorrect Analyte Targets
Randox Laboratories is recalling calibration sera due to realigned targets for AST and ALT. The recall affects 307 kits distributed nationwide and in several foreign locations.
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 involves calibration target adjustments rather than a direct safety hazard like contamination or structural failure.
Plain-English summary
Randox Laboratories Ltd. is recalling 307 kits of Randox Calibration Serum Level 3. This in vitro diagnostic product is intended for use as a calibration serum in clinical chemistry assays and contains 42 analytes based on lyophilized human serum.
The recall was initiated because the manufacturer realigned the RX Analyser Series calibration targets by 10% for AST and 9% for ALT. This adjustment was made in line with the Mean of All Instrument method target for the specific calibrator lot.
The affected product includes lot numbers 961UE onwards. The product was distributed nationwide and to foreign locations including Antigua, Aruba, Bahamas, Granada, and Tobago. Users should stop using the affected calibration sera and contact the manufacturer for further instructions.
The recalled product
- Product
- This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry…
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- Affected units
- 307
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)
- Lot Numbers: 961UE onwards GTN: 05055273200966
Distribution
Distributed nationwide across the United States.
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