Z-0398-03

SureStep 50 Test Strips, For the measurement of glucose in whole blood, Two bottles of 25 Test Srips...

Name: Z-0398-03 SureStep 50 Test Strips, For the measurement of glucose in whole blood, Two bottles of 25 Test Srips...
Creator: River City Drug
Published: 2002-10-08
License: https://open.fda.gov/license/

River City Drug / initiated 2002-10-08 / Terminated / root cause: labeling and UDI

FDA source

River City Drug began a recall of 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... on 2002-10-08. The reason FDA records is "Products labeled 'For Sale Outside The USA and Canada,' were being offered for sale in the U.S". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0398-03
Status: Terminated
Initiated: 2002-10-08
Posted: 2002-12-31
Terminated: 2005-09-07
Recalling firm: River City Drug
Product: 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.
Product code: JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Reason for recall: Products labeled 'For Sale Outside The USA and Canada,' were being offered for sale in the U.S.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Letters 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.
Quantity in commerce: 576 units
Distribution: Nationwide. 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.
Product codes and lots: Lot: E-169380A, Exp: 2003-01.

Product code JJQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)