Z-0743-2007

Mega Diagnostics Ammonia/Alcohol Controls (Cat.# A7504-CTL) packaged in 5ml vials

Name: Z-0743-2007 Mega Diagnostics Ammonia/Alcohol Controls (Cat.# A7504-CTL) packaged in 5ml vials
Creator: Mega Diagnostics
Published: 2006-09-20
License: https://open.fda.gov/license/

Mega Diagnostics / initiated 2006-09-20 / Terminated

FDA source

Mega Diagnostics began a recall of Mega Diagnostics Ammonia/Alcohol Controls (Cat.# A7504-CTL) packaged in 5ml vials on 2006-09-20. The reason FDA records is "Potential for microorganism growth in the alcohol standard and or unexpected QC changes in the Ammonia portion of the Ammonia/Alcohol control product". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0743-2007
Status: Terminated
Initiated: 2006-09-20
Posted: 2007-04-14
Terminated: 2012-06-04
Recalling firm: Mega Diagnostics
Product: Mega Diagnostics Ammonia/Alcohol Controls (Cat.# A7504-CTL) packaged in 5ml vials
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Potential for microorganism growth in the alcohol standard and or unexpected QC changes in the Ammonia portion of the Ammonia/Alcohol control product.
FDA root cause: Other
Action: The firm sent a recall notification to their customer in Indonesia and advised them to dispose of the product
Quantity in commerce: 12 Units
Distribution: Country of Indonesia
Product codes and lots: Lot# 522202

Product code JIX

K972333Class IIAmmonia/iron Standard KitVerichem Laboratories, Inc. / cleared 1997-07-23

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)