RecallRadar

FDA Device recall Z-1616-2014

ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters

On 2014-05-21 the FDA classified a Class II recall of ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters by Roche Diagnostics Operations, citing 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 inte….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1616-2014
ClassificationClass II
Statusterminated
Initiated2014-04-14
Published2014-05-21
Last updated2026-09-13 11:53 UTC
CompanyRoche Diagnostics Operations
DistributionUS

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.

Identifiers

code_info5599423160, 5599415160, 5919967160, 5919959160, 5919983160, 5907675001

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1616-2014%22

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