Link -ps_11-2013-glucomen.htm

The AEMPS informs the removal of the market of certain lots of reactive strips for the determination of blood glucose “Glucomen® LX Sensor”, manufactured by A. Menarini Diagnostics S.R.L., Italy, due to the possible obtaining of erroneously high values.

The Spanish Agency for Medicines and Health Products (AEMPS) has been informed by the company Menarini Diagnostics S.A., of the withdrawal of the market of certain lots of “reactive strips Glucomen® LX sensor”, manufactured by A. Menarini Diagnostics S.R.L., Italy.These strips are used with glucose glucose meters Glucomen® LX Plus.

The company has adopted this measure when determining that with certain lots of “reactive strips for the measurement of glucose blood glucomen® lx sensor” results could be obtained erroneously high results.

Identification of affected products in Spain

Lot numbers and reactive strips glucomen® lx sensor
REF 42204 GLUCOMEN LX SENSOR (50) LOT 3212219249 Expiration date 08-2014
REF 42330 GLUCOMEN LX Sensor (1 x 100) Lot 3212219249 Expiration date 08-2014
Current situation in Spain

The company has sent warning notes to the pharmacy offices and health centers, as well as a letter for patients, to warn of the problem detected and inform the withdrawal of lot 3212219249.

Recommendations

Patients
If you are a user of the “Glucomen® LX Sensor” reactive strips, manufactured by A. Menarini Diagnostics S.R.L., Italy, you must follow the following instructions:

Identify if the glucomen® lx sensor reactive strips available are affected.To do this
Representation of the label showing the "Lot" symbol

If you have reactive strips of the lot 3212219249:
Do not use them.
Entréguelas to the health professional who facilitated them or the pharmacy for replacement for a different lot.
Use another batch of reactive strips to continue controlling your glucose according to the guidelines indicated by your doctor.
If the reactive strips available do not correspond to Lot 3212219249, this security note does not affect you.
Pharmacy Office Health professionals:
If you have GLUCOMEN® LX Reactive strips Lot Sensor 3212219249, remove the products from the sale and contact the company for return.
If you have sold Glucomen® LX reactive strips Lot sensor 3212219249 to patients, try to identify them to share with them this information and to gather the return and replacement of the product.
Healthcare professionals:
Do not supply GLUCOMEN® LX Reactive strips Lot Sensor 3212219249 to patients.
If you have delivered reactive strips Glucomen® LX lot sensor 321219249 to patients, share this information with them to collect the return and replacement of the product.
Health professionals can communicate any incident related to the affected product, according to the procedure established in the guidelines for the application of the surveillance system by the centers and health professionals (Ref.: AEMPS/CTI-PS/October 2010) and the formsrelated

Company data

Menarini Diagnosticas, S.A.
Avda. Del Maresme, 120.
08918 Badalona.Barcelona.

Menarini Customer Service Diagnostics: 900 301 334
www.menarinidiag.es