ClearanceBrief
Recall Z-0207-2007 ยท NBW System, Test, Blood Glucose, Over The Counter

Medishop USA

OneTouch/Basic/Profile Blood Glucose Test Strips, 50 Test Strips per box. Part Number 020-848, LIFESCAN, a Johnson & Johnson company. (The product is labeled in English, Greek and Portuguese)

DateDec 8, 2006 (initiated Oct 17, 2006)
StatusTerminated
ReasonCounterfeit-(manufacturer unknown)
Root causeOther
ActionThe recalling firm faxed, e-mailed and/or mailed ''Urgent Medical Device'' letters and response forms (dated 10/17/06) to the 5 distributor accounts.
Quantity7,727 boxes (50 strips per box)
DistributionWorldwide Distribution-including the states of NY, NJ, MS and country of Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.