FDA Device recall Z-2121-2017
Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap
- FDA Device
- Class III
- terminated
- Published 2017-05-31
On 2017-05-31 the FDA classified a Class III recall of Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap by Medtest Holdings, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2121-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-05-15 |
| Published | 2017-05-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtest Holdings |
| Distribution | US |
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
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.
Identifiers
| code_info | Model Number(s): C7590-50 (Chemistry Control Level I), C7591-50 (Chemistry Control Level II), and C7592-100 (Chemistry Control Level I and II). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2121-2017%22
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