—#92107

Product

Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL) Anti-Sirolimus Coated Microparticles, 1 bottle (8.0 mL) Sirolimus Acridinium-labeled Conjugate in Citrate Buffer, and 1 bottle (10 mL) Assay Diluent containing saline; Abbott Laboratories, Abbott Diagnostics Division, Abbott Park, IL 60064 USA; list 01L76-25. The Architect Sirolimus assay is chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sirolimus in human whole blood on the Architect i System, as an aid in the management of renal transplant patients receiving sirolimus therapy.

FDA product code: NRP — Sirolimus Test System
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K070822
Affected lot / code info: Lot 80162M100, Expiry Date May 03, 2011

Why it was recalled

The Architect Sirolimus assay lot 80162M100 is exhibiting higher than normal reports of barcode read errors.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Abbott sent a "Product Recall" letter dated May 27, 2010, to all customers receiving the affected lot of reagent. The customers were informed of the increased frequency of barcode read errors due to the print quality of the barcode label. The following error codes have been observed for some kits within the lot: 4000 - Unable to read reagent bar code in position (x) on (y) carousel, 0208 - Reagent carousel scan error, and 2011 - Extra reagent bottle detected in position (x) on (y) carousel. The customers were requested to determine if they are currently using or have inventory of lot 80162M100, discontinue use of and destroy any remaining inventory of the lot, and retain a copy of the letter for their laboratory records. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688. Customers outside 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 including Puerto Rico, and countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, Venezuela and Vietnam.

Timeline

Recall initiated: 2010-05-27
Posted by FDA: 2010-08-03
Terminated: 2011-07-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #92107. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.