Class II — Abbott Laboratories
| Recalling firm | ABBOTT LABORATORIES |
|---|---|
| Registered facility | View this company's 64 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The product is leaking from the cap and crystallization was noted as present around the cap. |
| 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. |
| Quantity | 8868 units |
| Distribution | Worldwide Distribution - US (nationwide), Mexico, Colombia, Brazil, Germany, Hong Kong, Belgium, Czech Republic, Finland, Hungary, Ireland, China, New Zealand, Uruguay, Puerto Rico, St. Lucia, Austria, Croatia, Denmark, France, India, Isreal, Bermuda, Curacao, Cayman Islands, Jamaica, Canada, Bangladesh, Cyprus, Estonia, Greece, Indonesia, Italy, Kazakhstan, Latvia, Macedonia, Norway, Portugal, Ru… |
| Initiated | 2015-05-11 |
| Classified | 2015-06-08 |
| Terminated | 2016-06-27 |
| Recall number | Z-1725-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Abbott Laboratories (Z-1725-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71244/
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