Recall Z-2058-2014— Siemens Healthcare Diagnostics Inc.

Name: FDA recall Z-2058-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-09

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc., initiated 2014-06-09, terminated 2015-07-24. It names one FDA 510(k) clearance: K954755. Product: Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics. Reason: The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms..

Recalling firm: Siemens Healthcare Diagnostics Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-06-09
Terminated: 2015-07-24
Firm location: Los Angeles, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K954755 — COAT-A-COUNT DIRECT ANDROSTENEDIONEDiagnostic Products Corp.·cleared 1995-11-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics

Reason for recall

The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.

Data sourced from openFDA. This site is unofficial and independent of the FDA.