Sekisui Diagnostics Ammonia L3K¿ Assay — Class II medical device recall Z-1078-2017
Terminated recall by Sekisui Diagnostics P.E.I. Inc., reported 2017-02-01, distributed in CA, DE, FL, ID, IL, KS, MA, MI…. Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact
| Recall number | Z-1078-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sekisui Diagnostics P.E.I. Inc., Charlottetown, N/A, Canada |
| Recall initiated | 2016-11-29 |
| Classified | 2017-01-23 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2017-07-06 |
| Distributed | CA, DE, FL, ID, IL, KS, MA, MI, NJ, RI, TN, TX |
| Countries outside the US | AT, CA, CN, ES, IN, KR, LK, MX |
| Lot numbers | 48737, 48962, 48967, 49087, 49220, 49258, 49330, 49331, 49515 |
| Model numbers | 293-10, 293-80-91 |
Product
Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
Reason for recall
Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.
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-1078-2017. 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.