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U.S. Department of Health and Human Services

Class 2 Device Recall Agfa Cronex 10T

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  Class 2 Device Recall Agfa Cronex 10T see related information
Date Initiated by Firm December 21, 2005
Date Posted February 04, 2006
Recall Status1 Terminated 3 on April 18, 2006
Recall Number Z-0471-06
Recall Event ID 34274
Product Classification System, X-Ray, Film Marking, Radiographic - Product Code JAC
Product Agfa Cronex¿ 10T Radiographic film
Code Information Catalog number LF5D1, Manufacturing Batch or Lot: 79260070
Recalling Firm/
Manufacturer
AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Ray B. Myers Ph.D
864-864-1827
Manufacturer Reason
for Recall
Mislabeling; Product labeled Cronex¿ 10T actually contains Afga, Curix Ultra UVL Plus.
FDA Determined
Cause 2
Other
Action Consignees were first contact by telephone followed up with a certified letter, on/about 12/21/2005.
Quantity in Commerce 118 boxes
Distribution AZ, CA, CO, GA, IL, MI, NE, NV, OH, OR, WA and Canada
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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