Recall Z-1616-2014— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-1616-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-14

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2014-04-14, terminated 2014-09-18. It names one FDA 510(k) clearance: K113614. Product: ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count retail strip; 51 count MedBen strip 51 count Mail Order strip; Sample Kit 16 per case. The ACCU-CHEK Compact Plus Test Strips are for use with the ACCU-CHEK Compact Plus Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.. Reason: Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneously low blood glucose readings in patients undergoing Ceftriaxone therapy. The interference is not described in the product labeling..

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-04-14
Terminated: 2014-09-18
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K113614 — ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEMRoche Diagnostics·cleared 2013-02-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count retail strip; 51 count MedBen strip 51 count Mail Order strip; Sample Kit 16 per case. The ACCU-CHEK Compact Plus Test Strips are for use with the ACCU-CHEK Compact Plus Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.

Reason for recall

Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneously low blood glucose readings in patients undergoing Ceftriaxone therapy. The interference is not described in the product labeling.

Data sourced from openFDA. This site is unofficial and independent of the FDA.