Z-2361-2020 Class II Terminated
FDA device recall Z-2361-2020 was initiated by Abaxis Inc on December 11, 2019 and is designated Class II. Reason for recall: Incorrect reference ranges of analytes. The recall status is terminated (terminated July 22, 2022). Affected quantity: 15.
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2020
- Initiation Date
- December 11, 2019
- Termination Date
- July 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15
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.
Distribution Pattern
All U.S. Consignees, TX, PA, FL, OK, KY, CA, VA No OUS Consignees.
Code Information
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