Z-1725-2015Class II

Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is...

Name: Z-1725-2015 Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is...
Creator: Abbott Laboratories
Published: 2015-05-11
License: https://open.fda.gov/license/

Abbott Medical / initiated 2015-05-11 / Terminated

FDA source

Abbott Laboratories began a recall of 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... on 2015-05-11. FDA classified it as Class II and gives the reason as "The product is leaking from the cap and crystallization was noted as present around the cap". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1725-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-11
Posted: 2015-06-08
Terminated: 2016-06-27
Recalling firm: Abbott Medical
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The product is leaking from the cap and crystallization was noted as present around the cap.
FDA root cause: Under Investigation by firm
Action: Abbott Laboratories sent a Product Recall letter dated May 11, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to wear the appropriate Personal Protective Equipment (PPE) to determine if they have the affected product in their inventory. If customers observe any signs of leakage or loose caps discontinue use and disppose of any remaining inventory of those kits in accorance with their institutions's policies and procedures. If customers do not observe any signs of leakage or loose caps they may continue to use the product following the precautions per the ARCHITECT System Operations Manual and the Safety Data Sheet. Customers were also asked to complete and return the enclosed Customers Reply form. If affected product was forwarded to other laboratories, customers need to inform them of the Product Recalls and provide them a copy of tthe product recall letter. Customers should also maintain a copy of the recall letter. Customers with questions were instructed to contact Customer Service at 1-877-4ABBOTT. For questions regarding this recall call 224-668-1926.
Quantity in commerce: 8868 units
Distribution: 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.
Product codes and lots: Lot number 49059UN14, Expiration data 04-MAR-2016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1725-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1725-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-08

Product code JJE

K980367Class IIAeroset SystemAbbott Laboratories / cleared 1998-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)