Recall Z-2292-2019 ยท OOI Real Time Nucleic Acid Amplification System
Luminex Corporation
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
| Date | Aug 19, 2019 (initiated Jun 29, 2018) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | On July 10, 2018, the firm sent an "URGENT: FIELD SAFETY NOTICE" to customers via email (with a follow-up telephone call) informing them that they may have received an affected barcode scanner. The Notice explained that when the potentially affected barcode scanner is used on multiple ARIES cassettes at the same time, the system may prepopulate the Sample ID field with a previously stored sample ID. This field will be overwritten by scanning or manually entering a sample, but in the event the ARIES cassette is not scanned, the prepopulated field may cause the incorrect association of sample id |
| Quantity | 153 (140 U.S. and 13 O.U.S.) |
| Distribution | Worldwide distribution. US nationwide, Canada, Ireland, Netherlands, Singapore, Thailand, and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151917 | ARIES System Luminex Corporation, Oct 6, 2015 |
| K160517 | ARIES System Luminex Corporation, Apr 12, 2016 |
| K161495 | ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) Luminex Corporation, Jun 30, 2016 |
| K162772 | ARIES GBS Assay Luminex Corporation, Dec 23, 2016 |