Reported Aug 28, 2019 · Terminated
Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories.…
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?
- Luminex Aries M1 System ModelAries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories
- Scanner Label/LabelingJADAK JDK-2330 REV B 170512-017
- Lot codes and dates
- ARIES System UDI00840487101537
- ARIES M1 System UDI00840487100080 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
- Amount recalled
- 153 (140 U.S. and 13 O.U.S.)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new packaged foods recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.