ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic test kit; each kit co

FDA device recall Z-1509-2012 · posted 2012-05-10 · Terminated

Recall details

Recalling firm

Abbott Laboratories

Reason for recall

The lot of Troponin-I is demonstrating a shift in expected results in some cases, and varies from kit to kit. A concentration change of up to +/-55% could occur when switching kits without recalibrating.

Action taken

The firm, Abbott Laboratories, sent a "Product Recall Immediate Action Required"letter dated April 11, 2012 to all Troponin-I customers who received the affected reagent lot internationally. The customers were directed to determine if they are currently using and/or have inventory of lot 74264UN11; to discontinue use and destroy any remaining inventory of the lot; 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; to retain a copy of the letter for their records and to complete and return the Customer Reply Form (sent to Abbott international affiliates via e-mail on 4/11/2012) via fax to: 1-800-777-0051 or e-mail: QAGCO@abbott.com. Any questions were directed to their local Customer Service representative or call the field action coordinator at 847-938-1923 or email: albert.chianello@abbott.com.

Root cause

Material/Component Contamination

Status

Terminated

Product code

MMI

Quantity affected

8,723 kits

Distribution

International distribution only: including countries of: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bosnia & Herze, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cyprus,

Date initiated

2012-04-11

Date posted

2012-05-10

Date terminated

2016-12-23

Location

Abbott Park, IL

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