Z-0471-06

Agfa Cronex 10T Radiographic film

Name: Z-0471-06 Agfa Cronex 10T Radiographic film
Creator: AGFA Corp.
Published: 2005-12-21
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2005-12-21 / Terminated / root cause: labeling and UDI

FDA source

AGFA Corp. began a recall of Agfa Cronex 10T Radiographic film on 2005-12-21. The reason FDA records is "Mislabeling; Product labeled Cronex 10T actually contains Afga, Curix Ultra UVL Plus". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0471-06
Status: Terminated
Initiated: 2005-12-21
Posted: 2006-02-04
Terminated: 2006-04-18
Recalling firm: AGFA Healthcare Corp.
Product: Agfa Cronex 10T Radiographic film
Product code: JAC System, X-Ray, Film Marking, Radiographic
Reason for recall: Mislabeling; Product labeled Cronex 10T actually contains Afga, Curix Ultra UVL Plus.
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: Catalog number LF5D1, Manufacturing Batch or Lot: 79260070

Product code JAC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)