ClearanceBrief
Recall Z-0398-03 ยท JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

River City Drug

SureStep 50 Test Strips, For the measurement of glucose in whole blood, Two bottles of 25 Test Srips, LIFESCAN, a Johnson & Johnson Company, Milpitas, CA 95035, USA, Lot: E-169380A, Exp: 2003-01.

DateDec 31, 2002 (initiated Oct 8, 2002)
StatusTerminated
ReasonProducts labeled 'For Sale Outside The USA and Canada,' were being offered for sale in the U.S.
Root causeOther
ActionLetters were sent via regular mail to customers on/about 10/08/02 with a response card attached. Customers were informed of the recall, and were urged to contact their accounts and to return their outstanding recall stock to River City Drug for full credit.
Quantity576 units
DistributionNationwide. AZ, CA, DE, FL, GA, KY, KS, HI, IA, IL, LA, MA, MD, MI, MN, MO, NC, NM, NV, OH, OK, PA, SC, SD, TN, TX, VA, WA, WI, WV. There are no foreign or government accounts involved.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.