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Terminated

Drystar Mammo. Display of Mammographic images.

FDA Recall Z-0916-2012 · Posted None

Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeIWZ
Date Initiated2010-03-02
Date Terminated2012-02-14
Product Quantity2 boxes

Reason for Recall

Labeling problem

Firm Action

The firm, AGFA Corporation spoke to the customer directly via telephone concerning the mislabeled affected products. The firm also contacted the customer via e-mail on April 13, 2011 explaining the outcome of the customer complaint. Replacement product was sent to the customer.

Root Cause

Error in labeling

Distribution Pattern

Product distributed in Florida.

Official Source

View FDA Recall →

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

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