Terminated

Atellica Sample Handler Prime, Material Number 11069001

FDA Recall Z-1301-2019 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.

Recall StatusTerminated

Product CodeJGS

Date Initiated2019-03-07

Date Terminated2020-08-20

Product Quantity474

Reason for Recall

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

Firm Action

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

Root Cause

Under Investigation by firm

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)Siemens Healthcare Diagnostics · 2017-03-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.