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