FDA-Device2019-08-28Class II
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
Luminex Corporation
Hazard
An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in sample/patient mismatch or duplicate results (from other patients specimens) for a patient order.
Sold states
Worldwide distribution. US nationwide, Canada, Ireland, Netherlands, Singapore, Thailand, and United Kingdom
Affected count
153 (140 U.S. and 13 O.U.S.)
Manufactured in
12212 Technology Blvd, N/A, Austin, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2292-2019Don't want to check this manually?
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