Reported May 24, 2017 · Terminated
ARIES System and ARIES M1 System
Luminex Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Luminex Corporation · 12212 Technology Blvd · Austin, TX · 78727-6101
Is this the product you have?
- ARIES System and ARIES M1 System
- Lot codes and dates
- ARIES System UDI00840487101537
- and ARIES M1 System UDI00840487100080
- Amount recalled
- 15 units
Why it was recalled
The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems populates patient sample IDs with a previously scanned sample ID when entering orders into an ARIES instrument.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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