IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1

FDA device recall Z-2171-2010 · posted 2010-08-03 · Terminated

Recall details

Recalling firm

Abbott Laboratories

Reason for recall

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

Action taken

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.

Root cause

Other

Status

Terminated

Product code

NRP

Quantity affected

466 kits

Distribution

Worldwide distribution: USA and countries including Puerto Rico, Argentina, Austria, Bahrain, Brazil, Canada, Chile, China, Croatia, Cyprus, Egypt, France, Germany, Greece, Hungary, India, Israel, Ita

Date initiated

2010-04-30

Date posted

2010-08-03

Date terminated

2011-05-13

Location

Abbott Park, IL

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