FDA Device recall Z-2283-2019
ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
- FDA Device
- Class II
- ongoing
- Published 2019-08-21
On 2019-08-21 the FDA classified a Class II recall of ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295 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-2283-2019 |
| 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 HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
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 & discontinue use by dates for Part Number 50-10017: AA7308 - Immediately; AA7485 - 2/23/2019; AA7545 -…Lot numbers & discontinue use by dates for Part Number 50-10017: AA7308 - Immediately; AA7485 - 2/23/2019; AA7545 - 3/13/2019; AA7625 - 4/10/2019; AA7630 - 3/16/2019; AA7636 - 4/3/2019; AA7945 - 4/25/2019; AA7985 - 5/8/2019 |
|---|
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-2283-2019%22
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