Class 2 Device Recall Architect Alkaline Wash

• Date Initiated by Firm: May 11, 2015
• Date Posted: June 08, 2015
• Recall Status: Terminated on June 27, 2016
• Recall Number: Z-1725-2015
• Recall Event ID: 71244
• 510(K)Number: K980367
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• 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.
• Code Information: Lot number 49059UN14, Expiration data 04-MAR-2016.
• Recalling Firm/ Manufacturer: Abbott Laboratories; 100 Abbott Park Rd; Abbott Park IL 60064-3502
• For Additional Information Contact: 847-937-2550
• Manufacturer Reason for Recall: The product is leaking from the cap and crystallization was noted as present around the cap.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JJE and Original Applicant = ABBOTT LABORATORIES