Recall record at a glance
| Official record | Z-2028-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Report date | Jul 14, 2021 |
| Recall initiation date | May 13, 2021 |
| Quantity | US: 123 OUS: 751 |
| Location | Tarrytown, NY, United States |
Official product description
Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000
Why the product was recalled
Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.
Distribution information
Nationwide Foreign: Country Name Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile Colombia Croatia Cura¿ao Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Germany Greece Hungary India Indonesia Iraq Ireland Israel Italy Japan Kenya Kuwait Latvia Libya Lithuania Malaysia Mexico Morocco Netherlands New Zealand Norway Oman P.R. China Pakistan Peru Philippines Poland Portugal Qatar Republic Korea Romania Russian Fed. Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. Uganda Ukraine United Kingdom Uruguay Vatikancity Vietnam
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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