Pointe Scientific Lactate Dehydrogenase — Class II medical device recall Z-2165-2017
Terminated recall by Medtest Holdings, Inc., reported 2017-06-07, distributed nationwide. Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met.
| Recall number | Z-2165-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtest Holdings, Inc., Canton, MI, United States |
| Recall initiated | 2011-07-08 |
| Classified | 2017-05-26 |
| Reported by FDA | 2017-06-07 |
| Terminated | 2017-06-02 |
| Distributed | Nationwide (US) |
| Quantity | 716.146 l |
| Reason classes | specification failure |
| Model numbers | L7572 |
Product
Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.
Reason for recall
Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met.
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-2165-2017. 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.