FDA Device

Drystar Mammo. Display of Mammographic images.

Hazard

Labeling problem

What You Should Do

Remedy

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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Products

Drystar Mammo. Display of Mammographic images.
Brand
AGFA Corp.
UPC
ABC Code: EWCAK, size 8x10 inch Manufacturing lot: Emulsion Number: 36760074, cutting plan: B1AW1

Units Affected

2 boxes

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