Medtest Recalls Pointe Scientific Hitachi Total Bilirubin R1 Reagent
Medtest Holdings is recalling specific lots of Pointe Scientific Hitachi Total Bilirubin R1 Reagent due to decreased reactivity of the R1 component.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtest Holdings, Inc. is recalling specific lots of Pointe Scientific Hitachi Total Bilirubin R1 Reagent. The product is a two-part chemistry reagent 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.
The recall was initiated because of a decrease in the reactivity of the R1 component. The affected product quantity is 270.36 L. The recall covers specific catalog numbers and lot numbers, including Catalog # HB979-693, HB979-711, 7-HB979-R1-40, and 12-HB979-192.
The product was distributed worldwide in the states of IL, PR, CA, OR, MI, FL, NY, TX, OK, GA, VA and the country of Chile. Users should stop using the affected lots and contact Medtest Holdings, Inc. for further instructions.
The recalled product
- 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
- Manufacturer
- Medtest Holdings, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Catalog # HB979-693 Lot #'s: 025903-012
- 025903-278. Catalog # HB979-711 Lot #'s: 025903-009
- 025903-079
- 025903-080
- 025903-102
- 025903-278
- 025903-362.
Distribution
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