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Terminated

Hypoguard Advance Blood Glucose Strips, 10, 50, and 100 strip bottles.

FDA Recall Z-0275-04 · Posted 2003-12-25

Recalling FirmHypoguard USA, Inc.
Recall StatusTerminated
Product CodeCGA
Date Initiated2003-11-26
Date Terminated2005-11-21
Product Quantity10-count bottles 6336; 50-count bottles 73,490; and 100-count bottles 221

Reason for Recall

When actual blood glucose levels are in the low end of the blood glucose range, the recalled test strips may provide inaccurately high readings.

Firm Action

The consignees were sent letters dated 11/26/03 which requested that the product be returned.

Root Cause

Other

Distribution Pattern

The product was distributed to consignees located nationwide in the United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020232HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEMHypoguard USA, Inc. · 2002-02-12

Official Source

View FDA Recall →

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

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