Immunoassay Quality Control Material Recalled for Out-of-Range Values
Randox Laboratories is recalling Immunoassay Premium Control Tri Level quality control kits due to out-of-range values that caused delays in test result reporting. The affected lot was distributed to five states and Puerto Rico.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is out-of-range quality control values that could affect diagnostic accuracy, but the impact is indirect and theoretical. Class III recalls with theoretical hazards are typically scored at Moderate level.
Plain-English summary
Randox Laboratories Ltd. is recalling Immunoassay Premium Control Tri Level quality control kits (Catalog Number IA2633, Lot 583135) distributed to California, Illinois, Virginia, Washington, Wisconsin, and Puerto Rico, with an expiration date of April 28, 2023.
The recall involves quality control materials used for adrenocorticotropic hormone (ACTH) testing. The materials ran outside acceptable target values and ranges, causing delays in reporting test results. The out-of-range values required reassignment of calibration parameters on Roche Cobas e801 laboratory equipment.
Quality control materials are used to verify that diagnostic equipment is working correctly. When quality control values fall outside acceptable ranges, the reliability of patient test results may be affected.
The recalled product
- Product
- Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
- Manufacturer
- Randox Laboratories Ltd.
- Affected units
- 30
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)
- GTIN: 05055273203837 Batch/Lot Number: 583135 Exp. Date: 28th April 23
Distribution
Part of a larger recall action
This product is one of 2 recalled by Randox Laboratories Ltd. 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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