Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL) Anti-Sirolimus Coated Microparticles, 1 bot

FDA device recall Z-2172-2010 · posted 2010-08-03 · Terminated

Recall details

Recalling firm

Abbott Laboratories

Reason for recall

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

Action taken

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.

Root cause

Equipment maintenance

Status

Terminated

Product code

NRP

Quantity affected

875 kits

Distribution

Worldwide distribution: USA including Puerto Rico, and countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Egypt, Estonia, Finland, Fran

Date initiated

2010-05-27

Date posted

2010-08-03

Date terminated

2011-07-15

Location

Abbott Park, IL

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