Recalls / —
—#167351
Product
STREAMLAB - REFRIGERATED STORAGE MODULE 15000
- 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: 10482428; 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 #167351. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.