Recall Z-0081-2015 ยท JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Siemens Healthcare Diagnostics, Inc
External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
| Date | Oct 17, 2014 (initiated Sep 19, 2014) |
| 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. |
| Root cause | Process control |
| Action | Siemens sent an Urgent Field Safety Notice dated September 2014, to all by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on September 19, 2014 both in the United States and elsewhere for communication with affected customers. This notice informs customers of the issue with the power supply and the potentially affected products that may contain a damaged power supply. Consignees are asked to complete a Field Correction Effectiveness Check form and return in to Siemens Healthcare Diagnostics via Fax to (312) 275-7795. All affected domestic customers were sent a hard c |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091216 | CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 Siemens Healthcare Diagnostics, Oct 9, 2009 |