Home / Recalls / Medtest Holdings, Inc. / Z-2586-2017

Z-2586-2017 Class II Terminated

Recalled by Medtest Holdings, Inc. — Canton, MI

FDA device recall Z-2586-2017 was initiated by Medtest Holdings, Inc. on March 13, 2012 and is designated Class II. Reason for recall: Decrease reactivity of R 1 component. The recall status is terminated (terminated July 24, 2017). Affected quantity: 270.36 L.

Recall Details

Product Type
Devices
Report Date
June 21, 2017
Initiation Date
March 13, 2012
Termination Date
July 24, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
270.36 L

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.

Distribution Pattern

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

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.

Other recalls by Medtest Holdings, Inc.

  • Z-0389-2019 Class III — Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - (August 10, 2018)
  • Z-2063-2016 Class II — Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determinati (April 3, 2015)
  • Z-2316-2017 Class III — MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200 (October 23, 2014)
  • Z-2121-2017 Class III — Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/ (May 15, 2014)
  • Z-2116-2017 Class III — Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap (February 15, 2012)
  • Z-2650-2017 Class III — Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised (October 19, 2011)
  • Z-2165-2017 Class II — Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): (July 8, 2011)
  • Z-2649-2017 Class III — The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II (November 22, 2010)
  • Z-2631-2017 Class III — Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) (July 21, 2009)

FDA data resources