Analyzer and Atellica IM 1600 Analyzer system for in vitro… recallZ-1588-2018 · Siemens Healthcare Diagnostics, Inc. · initiated Feb 26, 2018
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
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
FDA root cause category: Software design
What the company is doing
Recall initiated 02/23/2018 Firm released an update software (SW) version (V), 1.12.1, which corrects the behavior. A Mandatory Update (MU) campaign was launched to install the new SW V on all systems, whether or not they are impacted by this behavior. The MU campaign will be tracked to 100% completion globally.
Recall details
- Recall number
- Z-1588-2018
- Status
- Terminated
- Initiated by the company
- Feb 26, 2018
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product code
- JJE
- FDA submissions
- K151792
- Distribution
- FL and France Spain Sweden United Kingdom Germany
Product description
Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
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
1 device cleared under K151792 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Atellica IM 1300 Analyzer 11066001Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE6 recalls188 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 79683).
- Z-1586-2018 · TerminatedAtelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
- Z-1587-2018 · TerminatedAtellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
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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