Device product
Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
Z-2361-2020
Product summary
- Firm
- Abaxis Inc
- Event
- Event 85533
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15
- Official record key
device-enforcement:Z-2361-2020
Official wording
Reason: Incorrect reference ranges of analytes.
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
Distribution pattern: All U.S. Consignees, TX, PA, FL, OK, KY, CA, VA No OUS Consignees.
Derived failure modes
-
Unknown
Incorrect reference ranges of analytes.