FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
- Recall number
- Z-1586-2018
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
- Status
- Terminated
- Initiated
- 2018-02-26
- Posted
- not on file
- Terminated
- 2020-05-12
- Reason
- When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
- Root cause
- Software design
- Action
- 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.
- Quantity
- not on file
- Distribution
- FL and France Spain Sweden United Kingdom Germany
- Lot, serial or model codes
- UDI 00630414007960
- 510(k) numbers
- ["K151792"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28