FDA Device recall Z-2361-2020
Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
- FDA Device
- Class II
- terminated
- Published 2020-06-24
On 2020-06-24 the FDA classified a Class II recall of Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II) by Abaxis, citing incorrect reference ranges of analytes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2361-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-11 |
| Published | 2020-06-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abaxis |
| Distribution | CA, FL, KY, OK, PA, TX, VA |
Product
Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
Reason
Incorrect reference ranges of analytes.
Identifiers
| code_info | Model Number: 1100-0000; 1100-0001; Software version 2.1.55 (NGA models )/3.1.35(Jen II models) Serial Numbers:0000000…Model Number: 1100-0000; 1100-0001; Software version 2.1.55 (NGA models )/3.1.35(Jen II models) Serial Numbers:0000000P23019, 0000000P02700 0000000P22997, 0000000P24435 0000000P05910 0000000P05380 0000000P08467 0000000P06595 0000000P07622 0000000P07988 0000000P04609 0000000P24721 0000000P24495 0000000P20399 0000000P20131 0000000P02755 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2361-2020%22
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