Recall Z-2361-2020— Abaxis Inc

Name: FDA recall Z-2361-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-11

Class II · Terminated

Class II FDA medical device recall by Abaxis Inc, initiated 2019-12-11, terminated 2022-07-22. It names one FDA 510(k) clearance: K934592. 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..

Recalling firm: Abaxis Inc
Classification: Class II
Status: Terminated
Initiated: 2019-12-11
Terminated: 2022-07-22
Firm location: Union City, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K934592 — EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTORAbaxis, Inc.·cleared 1994-04-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.