FDA Device recall Z-2116-2017
Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap
- FDA Device
- Class III
- terminated
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class III recall of Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap by Medtest Holdings, citing A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is listed as 0-600 U/L, wh….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2116-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-02-15 |
| Published | 2017-05-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtest Holdings |
| Distribution | US |
Product
Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.
Reason
A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is listed as 0-600 U/L, which is not consistent with the 510k submission package insert.
Identifiers
| code_info | Catalog numbers: HA461, HA761 , HA961 and lot codes:022204, 034801, 102401, 119503, and 134101. |
|---|
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-2116-2017%22
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