Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL

FDA device recall Z-1725-2015 · posted 2015-06-08 · Terminated

Recall details

Recalling firm

Abbott Laboratories

Reason for recall

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

JJE

Quantity affected

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

Date initiated

2015-05-11

Date posted

2015-06-08

Date terminated

2016-06-27

Location

Abbott Park, IL

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