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Recall Observatory FDA recall evidence

Device 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.

Z-1725-2015

May 11, 2015

Class II

Product summary

Firm
Abbott Laboratories
Event
Event 71244
Status
Terminated
Classification
Class II
Quantity
8868 units
Official record key
device-enforcement:Z-1725-2015

Official wording

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

Code information: Lot number 49059UN14, Expiration data 04-MAR-2016.

Distribution pattern: 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, Russia, Slovakia, Spain, Taiwan, UAE, Kenya, Lithuania, Malaysia, Philippines, Qatar, Saudi Arabia, Slovenia, Sweden, Tunisia, United Kingdom, Kuwait, Luxembourg, Netherlands, Poland, Romania, Singapore, South Africa, Switzerland, Turkey, and Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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