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U.S. Department of Health and Human Services

Class 2 Device Recall Piccolo Xpress chemistry analyzer

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  Class 2 Device Recall Piccolo Xpress chemistry analyzer see related information
Date Initiated by Firm December 11, 2019
Create Date June 12, 2020
Recall Status1 Terminated 3 on July 22, 2022
Recall Number Z-2361-2020
Recall Event ID 85533
510(K)Number k934592  
Product Classification Analyzer, chemistry, centrifugal, for clinical use - Product Code JJG
Product Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
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 
Recalling Firm/
Manufacturer		 Abaxis Inc
3240 Whipple Rd
Union City CA 94587-1217
For Additional Information Contact Matthew Rapp
510-474-9245
Manufacturer Reason
for Recall		 Incorrect reference ranges of analytes.
FDA Determined
Cause 2		 Software design
Action On January 9, 2020, the firm sent an "Urgent Medical Device Recall' to their customers, regarding the chemistry analyzer containing software versions software versions 2.1.55/3.1.3. 5. This software failure may cause the product to display the incorrect reference ranges for certain analytes when gender selection is not set on the device. Erroneous reference values may result in an incorrect diagnosis or treatment plan.The firm informed customers to immediately stop using the devices and return it to the firm. On January 21, 2020, the firm instructed their customers to check the enclosed list of affected analytes and their correct reference range values and informed them that the erroneous reference values may result in an incorrect diagnosis or treatment plan. The affected products are shipped between 11/29/19 and 12/3/19, as either a unit on loan or as a repair/service of unit. The firm instructed customers to immediately examine their inventory and quarantine the product subject to recall. The firm ceased further distribution or use of the product. The firm instructed to the customers that their Technical Support arranged for the product return to the firm and would provide the repaired or replacement at no cost. The firm provided the Technical Support number as 1-800-822-2947 for customers to contact them.
Quantity in Commerce 15
Distribution All U.S. Consignees, TX, PA, FL, OK, KY, CA, VA No OUS Consignees.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJG and Original Applicant = ABAXIS, INC.
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