Atellica Sample Handler Prime, Material Number 11069001 recallZ-1301-2019 · Siemens Healthcare Diagnostics, Inc. · initiated Mar 7, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There were multiple issues identified in the system software which required an update.
FDA root cause category: Under Investigation by firm
What the company is doing
Urgent Medical Device Correction notification letters dated 3/7/19 were sent to customers.
Recall details
- Recall number
- Z-1301-2019
- Status
- Terminated
- Initiated by the company
- Mar 7, 2019
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 474
- Product code
- JGS
- FDA submissions
- K161954
- Distribution
- 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.
Product description
Atellica Sample Handler Prime, Material Number 11069001
Code information (models, lots, serial numbers)
UDI: 00630414002026
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Atellica IM 1600 Analyzer 11066000Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE7 recalls196 reports
Other devices under the same FDA submission
2 devices cleared under K161954 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Atellica Sample Handler Prime 11069001Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall1 death146 reports
- Atellica CH Reaction Ring Segment 11099326Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall23 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 82602).
- Z-1299-2019 · TerminatedAtellica IM 1300 Analyzer, Material Number 11066001
- Z-1300-2019 · TerminatedAtellica IM 1600 Analyzer, Material Number 11066000
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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