Important Safety Alerts

Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom, has issued a medical device safety alert concerning CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systems, manufactured by Siemens. The material numbers of affected products are identified as follows:

• CLINITEK Status+: 10379675; 10379676; 10379677; 10379678; 10379679; 10379680; 10379681; 10697813; 10376324 (Legacy P/N: 1780),
• CLINITEK Status Connect System: 10376322; 10376323 (Legacy P/N: 1790); 10470849 (Legacy P/N: 1797),
• CLINITEK Status Power Supply Adaptor – Spare Part: 10378632; 10378633; 10378634;10309177; 10309178; 10324040; 10376820 This affects power supply adaptors embossed with the numerical date codes: 50130, 51130, 52130, 01140, 02140, 03140, 04140, 05140, 06140, 07140, 08140, 09140, 10140, 11140, 12140, 13140, 14140, 15140, 16140, 17140, 18140, 19140, 20140, 21140, 22140, and 23140.

The manufacturer has received customer complaints regarding damage to the external power supply adaptors that accompany the CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect urine analyzers, which can result in an increased potential for electric shock to the user.

Affected users are advised to discard all affected/ damaged adaptors. For CLINITEK Status or CLINITEK Status+ customers, instrument can still be run by battery power. Affected users are suggested to consult Operator's Guide for instructions. CLINITEK Status Connect systems, however, cannot be operated on battery power.

For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON457620

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 30 Sep 2014