—#94358

Product

Architect Tacrolimus Reagent Kit; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood; Abbott Laboratories, Abbott Diagnostics Division, Abbott Park, IL 60064 USA; list 1L77-25 The Architect Tacrolimus assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy.

FDA product code: MLM — Enzyme Immunoassay, Tracrolimus
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K070820
Affected lot / code info: list 1L77-25, lot number 86599M500, expiration date September 01, 2011

Why it was recalled

There are reagent barcode read errors when using reagent lot 86599M500 due to the print quality of the barcode.

Root cause (FDA determination)

Other

Action the firm took

Abbott Laboratories sent a "Product Recall Immediate Action Required" letter dated September 7, 2010, to all customers. The letter described product, problem and action to be taken by customers. The customers were instructed to determine if they are currently using and/or have inventory of lot 86599M500; discontinue use of and destroy any remaining inventory; inform and provide copies of letter to other laboratories if appropriate; retain the letter for laboratory records and complete and return the Customer Reply Immediate Action Required form via fax at 1-800-777-0051 or email QAGCO@abbott.com. IMPORTANT NOTE: If you do not currently have replacement material than you may continue to use this reagent lot until your laboratory receives replacement material. Upon receipt of the replacement material, discontinue use of and discard lot 86599M500 and switch to the replacement material. Contact Abbott Customer service for replacement material (1-877-4ABBOTT, Option 1). If you or any of the health care providers you serve have any questions regarding this information, U.S. customers should call Customers Service at 1-877-4ABBOTT. Customers outside of the U.S., please contact your local Customer Service representative.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: USA and countries including Puerto Rico, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Montenegro, Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Vietnam.

Timeline

Recall initiated: 2010-09-07
Posted by FDA: 2010-10-15
Terminated: 2011-05-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94358. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.