—#91137

Product

IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl Phosphate, 1.2 mM; Produced by Axis-Shield Diagnostics, Ltd., Dundee, UK for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA; list 5C91-21 The IMx Sirolimus assay is an in vitro reagent system for the quantitative determination of sirolimus in human whole blood 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: K042411
Affected lot / code info: Lot number 802873106, Expiry Date May13, 2010

Why it was recalled

IMx Sirolimus reagent lot 802873106 has exhibited an increased frequency of calibration errors.

Root cause (FDA determination)

Other

Action the firm took

Abbott sent a "Product Recall" letter dated April 30, 2010, to all customers receiving the affected lot of reagent. The accounts were informed of the increased frequency of calibration errors, including: 157 Check 1 Out of Range, 161 Check 5 Out of Range, and 173 Mode 1 deviation Factor High. The accounts were requested to determine if they are currently using or have inventory of lot 802873106, 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 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, Austria, Bahrain, Brazil, Canada, Chile, China, Croatia, Cyprus, Egypt, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Jordan, Lebanon, Lithuania, Netherlands, Norway, Philippines, Poland, Russia, Panama, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE and Venezuela.

Timeline

Recall initiated: 2010-04-30
Posted by FDA: 2010-08-03
Terminated: 2011-05-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91137. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.