Luminex ARIES System Recalled for Barcode Scanner Data Error
Luminex Corporation is recalling 15 ARIES Systems because a barcode scanner accessory may incorrectly populate patient sample IDs with previously scanned data.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 the hazard involves incorrect patient sample identification, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Luminex Corporation is recalling 15 units of the ARIES System and ARIES M1 System. The recall involves a hand-held barcode scanner used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems.
The recall is due to a software or functional defect where the scanner populates patient sample IDs with a previously scanned sample ID when entering orders into an ARIES instrument. This error could lead to incorrect identification of patient samples.
The affected units were distributed worldwide, including in the United States, Finland, and China. Users of these systems should stop using the affected barcode scanners and contact Luminex Corporation for further instructions.
The recalled product
- Product
- ARIES System and ARIES M1 System
- Manufacturer
- Luminex Corporation
- Affected units
- 15
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)
- ARIES System UDI: 00840487101537 and ARIES M1 System UDI: 00840487100080
Distribution
Distribution scope not specified by the agency.
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