Atellica IM 1600 Analyzer — Class II medical device recall Z-0125-2022
Ongoing recall by Siemens Healthcare Diagnostics, Inc, reported 2021-10-27, distributed in AZ, CA, CO, GA, ID, KS, MO, MT…. Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced whil
| Recall number | Z-0125-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2021-09-28 |
| Classified | 2021-10-16 |
| Reported by FDA | 2021-10-27 |
| Distributed | AZ, CA, CO, GA, ID, KS, MO, MT, NC, NE, NM, NV, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WY |
| Quantity | 1,733 |
Product
Atellica IM 1600 Analyzer, SMN 11066000
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0125-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.