Z-1543-06

Ammonia/alcohol Control Set for the quantitative determination of ammonia/alcohol in blood, Manufactured for...

Name: Z-1543-06 Ammonia/alcohol Control Set for the quantitative determination of ammonia/alcohol in blood, Manufactured for...
Creator: Pointe Scientific, Inc.
Published: 2006-06-09
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2006-06-09 / Terminated

FDA source

Pointe Scientific, Inc. began a recall of Ammonia/alcohol Control Set for the quantitative determination of ammonia/alcohol in blood, Manufactured for Pointe Scientific, Inc.; Catalog number A7504-CTL on 2006-06-09. The reason FDA records is "Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1543-06
Status: Terminated
Initiated: 2006-06-09
Posted: 2006-09-30
Terminated: 2007-11-20
Recalling firm: Horiba Instruments Incorporated
Product: Ammonia/alcohol Control Set for the quantitative determination of ammonia/alcohol in blood, Manufactured for Pointe Scientific, Inc.; Catalog number A7504-CTL.
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
FDA root cause: Other
Action: Consignees were notified via recall letter dated 6/9/06 and a second letter dated 6/21/06 extending the recall to additional products/lots, to cease using the products, conduct a recall to the user level, destroy products on hand and to notify the firm via the response form of the amount destroyed for replacement purposes.
Quantity in commerce: 44 units
Distribution: Worldwide distribution ---- including USA and countries of Canada, Ecuador, Germany, Greece, India, Mexico, Peru, Poland, Portugal, Trinidad, United Arab Emirates and United Kingdom.
Product codes and lots: Lot 522202, exp. 7/06.

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)