Z-2292-2019 Class II Terminated
FDA device recall Z-2292-2019 was initiated by Luminex Corporation on Jun 29, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Apr 28, 2021). Affected quantity: 153 (140 U.S. and 13 O.U.S.).
Recall Details
- Product Type
- Devices
- Report Date
- Aug 28, 2019
- Initiation Date
- Jun 29, 2018
- Termination Date
- Apr 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 153 (140 U.S. and 13 O.U.S.)
Product Description
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
Reason for Recall
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.
Distribution Pattern
Worldwide distribution. US nationwide, Canada, Ireland, Netherlands, Singapore, Thailand, and United Kingdom
Code Information
ARIES System UDI: 00840487101537 ARIES M1 System UDI: 00840487100080 ARIES-M12V1-IVD, ARIES System ARIES-M6V1-IVD, ARIES M1 System CN-0321-01, ARIES System Handheld Barcode Scanner All scanners manufactured after April 2017 and including Part Number JDK-2330 Rev B.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2292-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026