Randox Immunoassay Premium Plus Controls Recalled for Stability Issues
Randox Laboratories is recalling Immunoassay Premium Plus Controls because the ACTH component does not meet the stability claims in the product instructions.
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, fitting the 'Low' severity criteria for documentation or minor issues.
Plain-English summary
Randox Laboratories is recalling 199 kits of Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages) distributed nationwide in the United States. The recall involves specific catalog numbers IA3109, IA3110, IA3111, and IA3112, along with their associated lot numbers.
The recall was initiated because the ACTH in the Immunoassay Premium and Premium Plus quality control products does not meet the quoted reconstituted stability claim stated in the product Instructions for Use (IFU). This discrepancy may affect the reliability of the quality control results.
Users of these products should stop using the affected kits and contact Randox Laboratories for further instructions or a refund. The recall is classified as Class III by the FDA, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
- Manufacturer
- Randox Laboratories
- Hazard
- Affected units
- 199
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 (15)
- Catalog numbers: IA3109 (Lots: 1476EC
- 1573EC
- 1619EC) IA3110 (Lots 1477EDC
- 1599EDC
- 1621EC
- 1662EC) IA3111 (Lots: 1478EC
- 1508EC
- 1578EC
- 1647EC) IA3112 (Lots: 359199
- 377412
- 373302
- 382147
- 382679
- 395668
- 416979)
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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