Home / Recalls / Abbott Laboratories / Z-1725-2015

Z-1725-2015 Class II Terminated

Recalled by Abbott Laboratories — Abbott Park, IL

FDA device recall Z-1725-2015 was initiated by Abbott Laboratories on May 11, 2015 and is designated Class II. Reason for recall: The product is leaking from the cap and crystallization was noted as present around the cap. The recall status is terminated (terminated Jun 27, 2016). Affected quantity: 8868 units.

Recall Details

Product Type: Devices
Report Date: Jun 17, 2015
Initiation Date: May 11, 2015
Termination Date: Jun 27, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8868 units

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.

Reason for Recall

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

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.

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1725-2015
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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