Z-0355-04

Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30

Name: Z-0355-04 Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30
Creator: Abbott Laboratories Diagnostic Div
Published: 2003-12-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-12-22 / Terminated / root cause: labeling and UDI

FDA source

Abbott Laboratories Diagnostic Div began a recall of Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30 on 2003-12-22. The reason FDA records is "Complaints that instructions for use were not clear". 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-0355-04
Status: Terminated
Initiated: 2003-12-22
Posted: 2004-01-16
Terminated: 2004-09-21
Recalling firm: Abbott Medical
Product: Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30.
Product code: JGJ Photometric Method, Magnesium
Reason for recall: Complaints that instructions for use were not clear.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Firm sent customer letters dated 12/22/2003 which included updated instructions for use.
Quantity in commerce: 215
Distribution: Nationwide and to Mexico, Brazil, Sinagapore, Venezuela, Puerto Rico, Hong Kong, Colombia, Dominican Republic, Australia, Ecuador, Canada, New Zealand, Argentina, Germany, Bahamas, Grand Cayman, El Salvador.
Product codes and lots: This is not a lot specific issue.

Product code JGJ

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)