ARIES HSV 1&2 Assay — Class II medical device recall Z-2283-2019
Ongoing recall by Luminex Corporation, reported 2019-08-21, distributed in AK, AL, AZ, CA, CO, FL, GA, IL…. Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side
| Recall number | Z-2283-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Austin, TX, United States |
| Recall initiated | 2019-02-20 |
| Classified | 2019-08-15 |
| Reported by FDA | 2019-08-21 |
| Distributed | 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 |
| Countries outside the US | BE, CA, DE, GB, SG, TH |
| Reason classes | potency, specification failure, packaging |
| UPC / GTIN / UDI-DI | 00840487100295 |
| Model numbers | 50-10017, AA7308 |
Product
ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2283-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.