Piccolo Xpress chemistry analyzer — Class II medical device recall Z-2361-2020
Terminated recall by Abaxis Inc, reported 2020-06-24, distributed in CA, FL, KY, OK, PA, TX, VA. Incorrect reference ranges of analytes.
| Recall number | Z-2361-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abaxis Inc, Union City, CA, United States |
| Recall initiated | 2019-12-11 |
| Classified | 2020-06-12 |
| Reported by FDA | 2020-06-24 |
| Terminated | 2022-07-22 |
| Distributed | CA, FL, KY, OK, PA, TX, VA |
| Quantity | 15 |
| Serial numbers | 0000000P02700, 0000000P02755, 0000000P04609, 0000000P05380, 0000000P05910, 0000000P06595, 0000000P07622, 0000000P07988, 0000000P08467, 0000000P20131, 0000000P20399, 0000000P22997, 0000000P23019, 0000000P24435, 0000000P24495, 0000000P24721 |
| Model numbers | 1100-0000, 1100-1001 |
Product
Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
Reason for recall
Incorrect reference ranges of analytes.
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-2361-2020. 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.