Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
Reported: June 24, 2020 Initiated: December 11, 2019 #Z-2361-2020
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.
Details
- Recalling Firm
- Abaxis Inc
- Units Affected
- 15
- Distribution
- All U.S. Consignees, TX, PA, FL, OK, KY, CA, VA No OUS Consignees.
- Location
- Union City, CA
Frequently Asked Questions
What product was recalled? ▼
Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II). Recalled by Abaxis Inc. Units affected: 15.
Why was this product recalled? ▼
Incorrect reference ranges of analytes.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 24, 2020. Severity: Moderate. Recall number: Z-2361-2020.
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