Randox Human Assayed Multi-Sera Level 2 Recalled for Incorrect Control Values
Randox Laboratories is recalling Human Assayed Multi-Sera Level 2 controls due to incorrectly assigned target and range values for specific analytes.
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: The recall is classified as FDA Class II, but the hazard involves incorrect data values in a quality control product rather than a direct physical or biological threat to patients, fitting the criteria for a moderate severity labeling or data error.
Plain-English summary
Randox Laboratories, Limited is recalling specific lots of Human Assayed Multi-Sera Level 2, Model NO. HN1530. This product is intended for in vitro diagnostic use in the quality control of diagnostic assays, specifically for the control of accuracy.
The recall is due to the RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate, and Gamma-GT being incorrectly assigned in the affected lots. The affected lot codes are 1306UN, 1308UN, and 1309UN.
A total of 149 units were distributed in the United States across multiple states and Puerto Rico, with additional worldwide foreign distribution. Users should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.
- Manufacturer
- Randox Laboratories, Limited
- Hazard
- Affected units
- 149
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 (3)
- 1306UN
- 1308UN
- 1309UN
Distribution
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