Reported Jun 21, 2017 · Terminated
Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin…
Medtest Holdings, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtest Holdings, Inc. · 5449 Research Dr · Canton, MI · 48188-2261
Is this the product you have?
- Pointe Scientific Hitachi Total
- Bilirubin Rl Reagent Product UsageTwo 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
- Lot codes and dates
- 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.
- Amount recalled
- 270.36 L
Where it was sold
Why it was recalled
Decrease reactivity of R 1 component.
This product could cause temporary or reversible health problems — stop using it.
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