Recalls / —

—#128287

Product

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

FDA product code

CIZ — Radioimmunoassay, Androstenedione

Device class

Class 1

Medical specialty

Clinical Chemistry

510(k) numbers

K954755

Affected lot / code info

Lot No. TKAN1 batch 587 TKAN1 batch 588 TKAN1 batch 589 TKAN1 batch 590 TKAN1 batch 591 TKAN1 batch 592 TKAN1 batch 593 TKAN1 batch 594 TKAN1 batch 595 TKAN1 batch 596 TKAN1 batch 597 TKAN1 batch 598 TKAN1 batch 599 TKAN1 batch 600

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

A recall letter dated 6/9/14 was sent to all customers who purchased the Coat-A-Count Direct Androstenedione because the assay is demonstrating a higher frequency of results compared to alternate platforms. The letter informs the customers of the problems identified, risks to health, and actions to be taken. Customers are instructed to complete and return the Field Correction Effectiveness Check attached to the recall letter within 30 days.

Recalling firm

Firm

Siemens Healthcare Diagnostics Inc.

Address

5736 W 96th St, Los Angeles, California 90045-5544

Distribution

Distribution pattern

Worldwide Distribution. US nationwide including CA, MI, NC, NE, NY, OH, PA, TX, and VA; Argentina, Austria, Belgium, Bolivia, Canada, Chile, Colombia, Finland, Germany, Great Britain, Greece, India, Ireland, Italy, Japan, Korea, Netherlands, Paraguay, Peru, South Africa, Spain, Sweden, Switzerland, and Uruguay

Timeline

Recall initiated

2014-06-09

Posted by FDA

2014-07-15

Terminated

2015-07-24

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #128287. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.