Abbott Laboratories: Medical Device Recall in 2015 - (Recall #: Z-1725-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 11, 2015

Date Posted: June 17, 2015

Recall Number: Z-1725-2015

Event ID: 71244

Reason for Recall:

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

Status: Terminated

Product Quantity: 8868 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated