Z-0172-2009

AST R1 Reagent, 120 ml., Pointe Scientific, Inc., Canton, MI; Catalog no. 8-A7561-R1-120. For the...

Name: Z-0172-2009 AST R1 Reagent, 120 ml., Pointe Scientific, Inc., Canton, MI; Catalog no. 8-A7561-R1-120. For the...
Creator: Pointe Scientific, Inc.
Published: 2008-08-25
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2008-08-25 / Terminated / root cause: manufacturing process

FDA source

Pointe Scientific, Inc. began a recall of AST R1 Reagent, 120 ml., Pointe Scientific, Inc., Canton, MI; Catalog no. 8-A7561-R1-120. For the quantitative determination of aspartate amoinotransferase in... on 2008-08-25. The reason FDA records is "The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0172-2009
Status: Terminated
Initiated: 2008-08-25
Posted: 2008-10-22
Terminated: 2009-11-27
Recalling firm: Horiba Instruments Incorporated
Product: AST R1 Reagent, 120 ml., Pointe Scientific, Inc., Canton, MI; Catalog no. 8-A7561-R1-120. For the quantitative determination of aspartate amoinotransferase in human serum
Product code: CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
Reason for recall: The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Consignees were notified via recall letter dated 8/22/08 and mailed 8/25/08 to examine their inventory, dispose of any recalled product found, and to notify the firm for replacements. Contact Pointe Scientific Inc., at 1-800-757-5313 for assistance.
Quantity in commerce: 25 vials
Distribution: Nationwide, Bolivia, Ecuador, Greece, Indonesia, Mexico, Nepal, Philippines, Romania and Serbia.
Product codes and lots: Lot 728504-079; Exp. 4/09.

Product code CIT

K941132Class IILiquid Ast (Sgot)reagent SetPointe Scientific, Inc., / cleared 1994-05-02

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)