Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage:… — Class II medical device recall Z-2586-2017
Terminated recall by Medtest Holdings, Inc., reported 2017-06-21, distributed in CA, FL, GA, IL, MI, NY, OK, OR…. Decrease reactivity of R 1 component.
| Recall number | Z-2586-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtest Holdings, Inc., Canton, MI, United States |
| Recall initiated | 2012-03-13 |
| Classified | 2017-06-14 |
| Reported by FDA | 2017-06-21 |
| Terminated | 2017-07-24 |
| Distributed | CA, FL, GA, IL, MI, NY, OK, OR, PR, TX, VA |
| Countries outside the US | CL |
| Quantity | 270.36 l |
| Lot numbers | 025903-009, 025903-012, 025903-055, 025903-079, 025903-080, 025903-090, 025903-102, 025903-278, 025903-355, 025903-362 |
| Model numbers | 12-HB979-192, 7-HB979-R1-40, HB979-693, HB979-711 |
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 for recall
Decrease reactivity of R 1 component.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2586-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.