Serological Test Positive Control Shows False Negative Results for Hepatitis B
Randox Serology I Positive Control may test negative for Hepatitis B surface antigen (HBsAg) on certain analyzers despite being designed as a positive control, potentially affecting laboratory quality control procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or hospitalizations. The defective positive control for Hepatitis B detection represents a risk-of-harm scenario where a laboratory control failure could lead to missed equipment problems and potentially inaccurate patient results.
Plain-English summary
Randox Laboratories Ltd. is recalling the Randox Serology I Positive Control (Lot 036SR, expiration date March 28, 2023) due to incorrect reactivity for Hepatitis B surface antigen (HBsAg). The positive control is a reference material used in clinical laboratories to verify that testing equipment functions correctly by producing a positive result when tested.
On Ortho Vitros and Beckman Coulter DxI analyzers, the Randox Serology I Positive Control tests negative (non-reactive) for HBsAg. This defect undermines the control's intended function: to confirm proper equipment operation. Laboratories using this defective control may fail to detect equipment malfunctions that could result in inaccurate patient test results and delays in reporting.
The affected product was distributed nationwide to clinical laboratories in West Virginia and North Carolina. If you have this product, verify equipment performance using an alternative positive control and contact Randox Laboratories or your equipment manufacturer to obtain a replacement.
The recalled product
- Product
- The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is delivered as a liquid in a kit of 3 identical ready-to-use vials of 5 mL each.
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- defective-control
- false-negative
- hbsag
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: 05055273216509 Lot number: 036SR Exp Date: 28th March 2023
Distribution
Distributed nationwide across the United States.
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