Medtest Holdings, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2586-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: March 13, 2012

Date Posted: June 21, 2017

Recall Number: Z-2586-2017

Event ID: 77003

Reason for Recall:

Decrease reactivity of R 1 component.

Status: Terminated

Product Quantity: 270.36 L

Code Information:

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.

Distribution Pattern:

Worldwide Distribution in the states of IL, PR, CA, OR, MI, FL, NY, TX, OK, GA, VA and country of CHILE

Voluntary or Mandated:

Voluntary: Firm initiated