—#167349

Product

STREAMLAB CORE UNIT / LYNX WITH IOM

FDA product code: LXG — Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K082638
Affected lot / code info: Siemens Material Numbers: 10444806; UDI: 00630414949765

Why it was recalled

The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Urgent Medical Device Correction notification letters dated 8/14/18 were distributed 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, CT, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WV. The products were distributed to the following foreign countries: Australia, Austria, Bangladesh, Belgium, Canada, Croatia, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Libya, Netherlands, Philippines, Portugal, Saudi Arabia, Slovakia, Slovenia, Spain, Taiwan, Thaliand, UAE, UK.

Timeline

Recall initiated: 2018-08-14
Terminated: 2020-09-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167349. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.