FDA Device recall Z-1078-2017
Sekisui Diagnostics Ammonia L3K¿ Assay
- FDA Device
- Class II
- terminated
- Published 2017-02-01
On 2017-02-01 the FDA classified a Class II recall of Sekisui Diagnostics Ammonia L3K¿ Assay by Sekisui Diagnostics P E I, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1078-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-29 |
| Published | 2017-02-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Sekisui Diagnostics P E I |
| Distribution | CA, DE, FL, ID, IL, KS, MA, MI, NJ, RI, TN, TX |
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
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.
Identifiers
| code_info | Catalog Number: 293-80-91; Lot Numbers: 48737, 48962, 49087, 49220, 49258 and Catalog Numbers: 293-10; Lot Numbers: 48967, 49330, 49331, 49515 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1078-2017%22
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