Z-1114-2008

Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine...

Name: Z-1114-2008 Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine...
Creator: Pointe Scientific, Inc.
Published: 2007-12-14
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2007-12-14 / Terminated / root cause: manufacturing process

FDA source

Pointe Scientific, Inc. began a recall of Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 610 ml, Catalog no. HA926-610, in... on 2007-12-14. The reason FDA records is "Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms". 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-1114-2008
Status: Terminated
Initiated: 2007-12-14
Posted: 2008-05-22
Terminated: 2008-09-15
Recalling firm: Horiba Instruments Incorporated
Product: Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 610 ml, Catalog no. HA926-610, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188
Product code: CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
Reason for recall: Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Pointe Scientific notified consignees via Urgent Medical Device Recall letters dated 12/14/07, instructed to dispose of the product and to send back a reply form to request replacement product.
Quantity in commerce: 955 for all products.
Distribution: Worldwide Distribution - USA, Bolivia, Canada, Chile, China, Cyprus, Greece, Indonesia, Israel, Korea, Mexico, Pakistan, Panama, Peru, Philippines, Republic of Yemen, Russia, South Africa, Trinidad, Ukraine and West Indies.
Product codes and lots: Lots 628302-004 and 704601-113.

Product code CKA

K941287Class ILiquid Alt(sgpt) Reagent SetPointe Scientific, Inc., / cleared 1994-05-03

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)