Recalls / —

—#172012

Product

Atellica IM 1300 Analyzer, Material Number 11066001

FDA product code

JLW — Radioimmunoassay, Thyroid-Stimulating Hormone

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K151792

Affected lot / code info

UDI: 00630414007960

Why it was recalled

There were multiple issues identified in the system software which required an update.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Urgent Medical Device Correction notification letters dated 3/7/19 were sent to customers.

Recalling firm

Firm

Siemens Healthcare Diagnostics, Inc.

Address

511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA, WV, WY, and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. China, Pakistan, Poland, Portugal Republic of Korea, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, UK, and Vietnam.

Timeline

Recall initiated

2019-03-07

Terminated

2020-08-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #172012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.