FDAFDA · Food and drugs·Recall number Z-2586-2017
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.
Published June 21, 2017 · Recall initiated: March 13, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Decrease reactivity of R 1 component.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Medtest Holdings, Inc.
- Distributor
- Worldwide Distribution in the states of IL, PR, CA, OR, MI, FL, NY, TX, OK, GA, VA and country of CHILE
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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