Recall Z-2586-2017— Medtest Holdings, Inc.

Name: FDA recall Z-2586-2017
Creator: U.S. Food and Drug Administration
Published: 2012-03-13

Class II · Terminated

Class II FDA medical device recall by Medtest Holdings, Inc., initiated 2012-03-13, terminated 2017-07-24. It names one FDA 510(k) clearance: K040391. 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.. Reason: Decrease reactivity of R 1 component..

Recalling firm: Medtest Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-03-13
Terminated: 2017-07-24
Firm location: Canton, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K040391 — TOTAL BILIRUBIN REAGENT SETPointe Scientific, Inc.,·cleared 2004-06-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

Decrease reactivity of R 1 component.

Data sourced from openFDA. This site is unofficial and independent of the FDA.