Randox recalls Human Assayed Multi-Sera Level 2 (HN1530) due to incorrect control values in specific lots. This may cause inaccurate diagnostic test results. Affected units include model HN1530 with serial numbers 1306UN, 1308UN, 1309UN.
The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.
Randox is recalling Human Assayed Multi-Sera Level 2 (model HN1530) because specific lots have incorrect control values for diagnostic tests. This could lead to inaccurate test results if used in quality control. The recall affects units sold with serial numbers 1306UN, 1308UN, and 1309UN.
The control values for ALT, Bicarbonate, and Gamma-GT in specific lots are incorrectly assigned. This could cause diagnostic tests to produce inaccurate results if the control is used in quality control checks.
Laboratories using the Human Assayed Multi-Sera Level 2 (HN1530) for in vitro diagnostic tests are affected. Those using specific lots with serial numbers 1306UN, 1308UN, or 1309UN are most at risk.
Check for the model number HN1530 on the product. Look for serial numbers 1306UN, 1308UN, or 1309UN on the packaging or label.
Look for serial numbers 1306UN, 1308UN, or 1309UN on the product packaging or label.
The recalled product is Human Assayed Multi-Sera Level 2, Model HN1530.
Serial numbers 1306UN, 1308UN, and 1309UN are affected.
Incorrect control values in specific lots could lead to inaccurate diagnostic test results if used in quality control checks.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2150-2019 — Randox Randox Hello, I own a Randox that is covered by recall Z-2150-2019 from Randox. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
