Z-1014-2010

Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250

Name: Z-1014-2010 Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250
Creator: Pointe Scientific, Inc.
Published: 2009-07-29
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2009-07-29 / Terminated / root cause: labeling and UDI

FDA source

Pointe Scientific, Inc. began a recall of Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250 on 2009-07-29. The reason FDA records is "R2 reagent component may fail because it may contain R1 reagent. The reagent was rendered inoperative and would not pass the required quality control (calibration and quality control testing) before beginning running...". 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-1014-2010
Status: Terminated
Initiated: 2009-07-29
Posted: 2010-03-05
Terminated: 2010-12-06
Recalling firm: Horiba Instruments Incorporated
Product: Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250.
Product code: CIG Diazo Colorimetry, Bilirubin
Reason for recall: R2 reagent component may fail because it may contain R1 reagent. The reagent was rendered inoperative and would not pass the required quality control (calibration and quality control testing) before beginning running the bilirubin assay.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Consignee was notified by letter dated 7/29/2009 and instructed to identify and notify them at once of this product recall. Product is to be returned or destroyed. Customers with questions should contact the firm directly.
Quantity in commerce: 2
Distribution: California.
Product codes and lots: Lot 817103-337.

Product code CIG

K040391Class IITotal Bilirubin Reagent SetPointe Scientific, Inc., / cleared 2004-06-02

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)