FDA Device recall Z-1725-2015
Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers
- FDA Device
- Class II
- terminated
- Published 2015-06-17
On 2015-06-17 the FDA classified a Class II recall of Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers by Abbott Laboratories, citing the product is leaking from the cap and crystallization was noted as present around the cap.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1725-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-11 |
| Published | 2015-06-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
Product
Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room temperature and is shipped ready to use.
Reason
The product is leaking from the cap and crystallization was noted as present around the cap.
Identifiers
| code_info | Lot number 49059UN14, Expiration data 04-MAR-2016. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1725-2015%22
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