ABX PENTRA Reagent Container — Class II medical device recall Z-0902-2015
Terminated recall by Horiba Instruments, Inc dba Horiba Medical, reported 2015-01-14, distributed nationwide. HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they do not always sit properly into
| Recall number | Z-0902-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical, Irvine, CA, United States |
| Recall initiated | 2014-11-13 |
| Classified | 2015-01-02 |
| Reported by FDA | 2015-01-14 |
| Terminated | 2015-03-19 |
| Distributed | Nationwide (US) |
| Quantity | 443 units |
| Model numbers | B1037307 |
Product
ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
Reason for recall
HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm. The defect would result in a false high or false low results for HbA1c and false high results for magnes
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-0902-2015. 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.