Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP… — Class III medical device recall Z-2116-2017
Terminated recall by Medtest Holdings, Inc., reported 2017-05-24, distributed nationwide. A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500
| Recall number | Z-2116-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtest Holdings, Inc., Canton, MI, United States |
| Recall initiated | 2012-02-15 |
| Classified | 2017-05-18 |
| Reported by FDA | 2017-05-24 |
| Terminated | 2017-06-02 |
| Distributed | Nationwide (US) |
| Quantity | 119.168 l |
| Lot numbers | 022204, 034801, 102401, 119503, 134101 |
| Model numbers | HA461, HA761, HA961 |
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 for recall
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.
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-2116-2017. 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.