Alkaline Wash — Class II medical device recall Z-1725-2015
Terminated recall by Abbott Laboratories, reported 2015-06-17, distributed nationwide. The product is leaking from the cap and crystallization was noted as present around the cap.
| Recall number | Z-1725-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Abbott Park, IL, United States |
| Recall initiated | 2015-05-11 |
| Classified | 2015-06-08 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2016-06-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BD, BE, BM, BR, CA, CH, CN, CO, CW, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IN, IT, JM, KE, KW, KY, LT, LU, LV, MX, MY, NL, NO, NZ, PH, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, TN, TR, TW, UY, VN, ZA |
| Quantity | 8,868 units |
| Reason classes | packaging |
| Lot numbers | 49059UN14 |
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 for recall
The product is leaking from the cap and crystallization was noted as present around the cap.
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-1725-2015. 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.