FDA Device recall Z-0124-2022
Atellica IM 1300 Analyzer, SMN 11066001
- FDA Device
- Class II
- ongoing
- Published 2021-10-27
On 2021-10-27 the FDA classified a Class II recall of Atellica IM 1300 Analyzer, SMN 11066001 by Siemens Healthcare Diagnostics, citing ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft)….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0124-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-28 |
| Published | 2021-10-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | AZ, CA, CO, GA, ID, KS, MO, MT, NC, NE, NM, NV, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WY |
Product
Atellica IM 1300 Analyzer, SMN 11066001
Reason
Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.
Identifiers
| code_info | All units |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0124-2022%22
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