—#137004

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.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K980367
Affected lot / code info: Lot number 49059UN14, Expiration data 04-MAR-2016.

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Abbott Laboratories
Address: 100 Abbott Park Rd, Abbott Park, Illinois 60064-3502

Distribution

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.

Timeline

Recall initiated: 2015-05-11
Posted by FDA: 2015-06-08
Terminated: 2016-06-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137004. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.