FDA Medical Device Recalls (openFDA)
Abbott Laboratories: 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.
- Recall number
- Z-1725-2015
- Recalling firm
- Abbott Laboratories
- 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.
- Status
- Terminated
- Initiated
- 2015-05-11
- Posted
- 2015-06-08
- Terminated
- 2016-06-27
- Reason
- The product is leaking from the cap and crystallization was noted as present around the cap.
- 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
- 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.
- Lot, serial or model codes
- Lot number 49059UN14, Expiration data 04-MAR-2016.
- 510(k) numbers
- ["K980367"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1415939
- Firm city
- Abbott Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28