Medical device recalls Moderate risk

Abbott Laboratories recalls Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 m…

Recall date
May 11, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1725-2015
FDA classification
Class II
Brand / firm
Abbott Laboratories
Sold / distributed
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, Bangl…

Why it was recalled

The product is leaking from the cap and crystallization was noted as present around the cap.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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