ABX Pentra Micro ALBUMIN 2 CP — Class II medical device recall Z-2286-2018
Terminated recall by Horiba Instruments, Inc dba Horiba Medical, reported 2018-07-04, distributed nationwide. When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately after an ABX Pen
| Recall number | Z-2286-2018 |
|---|---|
| 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 | 2018-04-26 |
| Classified | 2018-06-25 |
| Reported by FDA | 2018-07-04 |
| Terminated | 2019-09-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | BG, DE, FR, IT, LB, PL, PT, RO, SA, TH, ZA |
| Model numbers | 1300032563 |
Product
ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.
Reason for recall
When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately after an ABX Pentra Creatinine 120 CP (CREA3) Reagent 2 dispense, the final result of the microalbumin may be elevated more than 10%. This increase may affect serum, plasma and urine sample types.
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-2286-2018. 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.