Recalls / —

—#91332

Product

Stratus CS Acute Care Troponin I TestPak ( Troponin I assay)

FDA product code

MMI — Immunoassay Method, Troponin Subunit

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K051650

Affected lot / code info

lot# 239229002, EXP# 2/13/2010  lot# 239236002, EXP2/20/2010  lot# 239243002, EXP# 2/7/2010 lot# 239257002, EXP# 3/10/2010 lot# 239264002, EXP# 3/20/2010 lot# 239271002, EXP# 3/27/2010 lot# 239278002, EXP# 4/3/2010 lot# 239285002, EXP# 4/10/2010 lot# 239292002, EXP# 4/17/2010 lot# 239299002, EXP# 4/24/2010 lot# 239313002, EXP 5/8/2010 lot# 239334002, EXP 5/29/2010 lot# 239341002, EXP#6/5/2010 lot# 239362002, EXP# 6/26/2010

Why it was recalled

False elevated Stratus CS CTNI results

Root cause (FDA determination)

Process control

Action the firm took

Recalling firm issued " Urgent Field Safety Notice" dated April 2010, informing users of the problem and to discuss with laboratory directors regarding the need to review previous test results, conduct patient follow up, and/or repeat testing for tests conducted on or after Nov 1, 2009.

Recalling firm

Firm

Siemens Healthcare Diagnostics, Inc.

Address

500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

Distribution pattern

Nationwide Distribution

Timeline

Recall initiated

2010-04-13

Posted by FDA

2010-09-11

Terminated

2010-10-25

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #91332. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.