ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2K41-30 (2000 test ki

FDA device recall Z-0855-2007 · posted 2007-06-14 · Terminated

Recall details

Recalling firm

Abbott Laboratories MPG

Reason for recall

False Negative Results : The analytical sensitivity claim of less than or equal to 0.01 ng/mL (ug/L) might not be met for all lots of Architect STAT Troponin-I reagents, thus false negative results may occur with negative results less than 0.1 ng/mL

Action taken

Abbott sent a Product Correction letter on 3/8/07 to all Troponin-I customers who received reagent lots in the last 12 months. The letters informed the accounts that the analytical sensitivity claim of = 0.01 ng/mL might not be met for all lots of Architect STAT Troponin-I reagents. The accounts were directed to evaluate the information the information provided in the letter against the reference range used in their laboratory to determine if any action needs to be taken; to follow their facility's policies and procedures for communicating with the heath care providers they serve; to forward a copy of the letter to any laboratory to whom they may have forwarded the reagent; and to retain a copy of the letter for their records. Any questions were directed to Abbott Customer Support at 1-877-4ABBOTT in the U.S. A follow-up press release was issued on 5/25/07 and a follow-up letter was issued on 5/29/07, providing updated instructions for laboratories to follow when using the product.

Root cause

Other

Status

Terminated

Product code

MMI

Quantity affected

9,438 kits

Distribution

Worldwide: USA including Puerto Rico, and internationally to Canada, Brazil, Germany, Japan, Taiwan, Hong Kong, Thailand, South Korea, Australia, New Zealand, Mexico, Colombia, Chile, Argentina and Tr

Date initiated

2007-03-08

Date posted

2007-06-14

Date terminated

2008-07-16

Location

Abbott Park, IL

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