FDA Device recall Z-1294-2019
Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washi…
- FDA Device
- Class II
- terminated
- Published 2019-05-15
On 2019-05-15 the FDA classified a Class II recall of Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washi… by Medica, citing wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Lipase (LIP) assay on the EasyRA clinical chemistry analyzer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1294-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-02-06 |
| Published | 2019-05-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medica |
| Distribution | US |
Product
Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wash solution in the wedge is used to prevent interference between certain tests.
Reason
Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Lipase (LIP) assay on the EasyRA clinical chemistry analyzer.
Identifiers
| code_info | Lot #s 18066, 18133, 18235, 18317 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1294-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.