FDA Device recall Z-2284-2019
ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
- FDA Device
- Class II
- ongoing
- Published 2019-08-21
On 2019-08-21 the FDA classified a Class II recall of ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158 by Luminex, citing through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2284-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-02-20 |
| Published | 2019-08-21 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Luminex |
| Distribution | AK, AL, AZ, CA, CO, FL, GA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, TN, TX, UT, VA, VT, WA, WI |
Product
ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
Reason
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Identifiers
| code_info | Lot numbers and discontinue use by dates for Part Number 50-10020: AA7127 - Immediately; AA7206 - Immediately; AA7…Lot numbers and discontinue use by dates for Part Number 50-10020: AA7127 - Immediately; AA7206 - Immediately; AA7312 - 3/5/2019; AA7549 - 3/30/2019; AA7635 - 4/10/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2284-2019%22
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