Class II — Siemens Healthcare Diagnostics, Inc
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User. |
| Product | External power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status system is a urine analyzer. |
| Quantity | approx. 4200 |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and Internationally Canada, Mexico, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Latvia, Malaysia, Mexico, Mor… |
| Initiated | 2014-09-19 |
| Classified | 2014-10-16 |
| Terminated | 2015-07-20 |
| Recall number | Z-0082-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics, Inc (Z-0082-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69228/
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