RecallDepth

Drystar Mammo. Display of Mammographic images.

Company
Agfa Corp.
Recall Initiated
March 2, 2010
Terminated
February 14, 2012
Recall Number
Z-0916-2012
Quantity
2 boxes
Firm Location
Greenville, SC

Reason for Recall

Labeling problem

Distribution

Product distributed in Florida.

Lot / Code Info

ABC Code: EWCAK, size 8x10 inch Manufacturing lot: Emulsion Number: 36760074, cutting plan: B1AW1

Root Cause

Error in labeling

Action Taken

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.

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