Z-2586-2017Class II

Pointe Scientific Hitachi Total Bilirubin Rl Reagent

Name: Z-2586-2017 Pointe Scientific Hitachi Total Bilirubin Rl Reagent
Creator: Medtest Holdings, Inc.
Published: 2012-03-13
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2012-03-13 / Terminated / root cause: manufacturing process

FDA source

Medtest Holdings, Inc. began a recall of Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total... on 2012-03-13. FDA classified it as Class II and gives the reason as "Decrease reactivity of R 1 component". 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-2586-2017
Classification: Class II
Status: Terminated
Initiated: 2012-03-13
Posted: 2017-06-14
Terminated: 2017-07-24
Recalling firm: Horiba Instruments Incorporated
Product: Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.
Product code: CIG Diazo Colorimetry, Bilirubin
Reason for recall: Decrease reactivity of R 1 component.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 3/13/2012 and 5/3/2012, Field Correction Notice notifications were sent to the affected consignees via e-mail/fax. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities.
Quantity in commerce: 270.36 L
Distribution: Worldwide Distribution in the states of IL, PR, CA, OR, MI, FL, NY, TX, OK, GA, VA and country of CHILE
Product codes and lots: Catalog # HB979-693 Lot #'s: 025903-012; 025903-278. Catalog # HB979-711 Lot #'s: 025903-009; 025903-079; 025903-080; 025903-102; 025903-278; 025903-355. Catalog # 7-HB979-R1-40 Lot #: 025903-055. Catalog # 12-HB979-192 Lot #'s: 025903-090; 025903-362.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2586-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2586-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14

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)