Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass… — Class III medical device recall Z-2121-2017
Terminated recall by Medtest Holdings, Inc., reported 2017-05-31, distributed nationwide. The original mean assigned to the control too high, upon reassignment with additional data the new assigned me
| Recall number | Z-2121-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtest Holdings, Inc., Canton, MI, United States |
| Recall initiated | 2014-05-15 |
| Classified | 2017-05-20 |
| Reported by FDA | 2017-05-31 |
| Terminated | 2017-06-02 |
| Distributed | Nationwide (US) |
| Quantity | 132,919 vol |
| Model numbers | C7590-50 |
Product
Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.
Reason for recall
The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.
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-2121-2017. 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.