Randox Recalls Immunoassay Premium Controls Due to Stability Claim Failure
Randox Laboratories is recalling 117 kits of Immunoassay Premium Controls because the ACTH component does not meet the stated reconstituted stability claim in the product instructions for use.
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 FDA classified this recall as Class III, which the rubric defines as typically scoring 1 or 2 because they are by definition unlikely to cause adverse health consequences. No injuries or illnesses were reported.
Plain-English summary
Randox Laboratories has initiated a recall of Immunoassay Premium Controls, available in 3x4x5mL and 12x5mL packages. The company is recalling 117 kits distributed nationwide across the United States. The affected products include specific catalog numbers and lots: IA2633 (Lots 398703, 402366), IA2638 (Lot 1666EC), IA2639 (Lots 1486EC, 1516EC, 1626EC), and IA2640 (Lots 1517EC, 1668EC).
The recall is necessary because the ACTH in these Immunoassay Premium and Premium Plus quality control products does not meet the quoted reconstituted stability claim found in the product's Instructions for Use (IFU). This means the product may not remain stable or accurate for the duration claimed by the manufacturer after reconstitution.
The U.S. Food and Drug Administration has classified this recall as Class III. The agency states that Class III recalls are typically unlikely to cause adverse health consequences. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
- Manufacturer
- Randox Laboratories
- Hazard
- Affected units
- 117
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 (5)
- Catalog numbers: IA2633 (Lots: 398703
- 402366) IA2638 (Lot 1666EC) IA2639 (Lots: 1486EC
- 1516EC
- 1626EC) IA2640 (Lots 1517EC
- 1668EC)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Randox Laboratories under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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