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Terminated

OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test Strips (hospital use)

FDA Recall Z-0630-03 · Posted 2003-03-12

Recalling FirmLifescan Inc
Recall StatusTerminated
Product CodeCGA
Date Initiated2003-01-13
Date Terminated2003-08-21
Product Quantity3,679,000 units

Reason for Recall

The Test Strips have manufacturing errors, in that the 'Confirmation Dot' is off-center or split in half, and defective bottle Cap.

Firm Action

Firm contacted all accounts by letters of 1/13/03 requesting replacement of the recall product.

Root Cause

Other

Distribution Pattern

Distribution of the product is worldwide and nationwide. Distribution in the United States was between April/02 to June/02. U.S. Government/Military or Canadian distribution is unknown at this time.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970556SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc. · 1997-05-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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