Luminex Aries M1 Barcode Scanner Recall for Sample Mismatch Risk
Luminex is recalling Aries M1 barcode scanners due to incorrect control boards that could cause patient sample mismatches or duplicate results.
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: The recall is classified as FDA Class II and involves a risk of harm (sample/patient mismatch) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Luminex Corporation is recalling the Luminex Aries M1 System, specifically the Hand Held Barcode Scanners, due to a defect in the control board and firmware. The recall affects 153 units, including 140 in the United States and 13 outside the U.S., which were distributed worldwide to locations including Canada, Ireland, the Netherlands, Singapore, Thailand, and the United Kingdom.
The defect involves an incorrect control board and firmware installed in some of the scanners. This issue could result in a sample or patient mismatch, or the generation of duplicate results from other patients' specimens for a specific patient order. The affected scanners are identified by the label JADAK JDK-2330 REV B 170512-017 and include all scanners manufactured after April 2017 with Part Number JDK-2330 Rev B.
Clinical laboratories using these devices should stop using the affected scanners and contact Luminex Corporation for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017
- Manufacturer
- Luminex Corporation
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 (2)
- ARIES System ARIES-M6V1-IVD
- ARIES M1 System CN-0321-01
Distribution
Distributed nationwide across the United States.
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