Abaxis Inc Recalls
Showing 1-3 of 3 recalls
Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
Incorrect reference ranges of analytes.
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.
Piccolo Chemistry Analyzer software version 6.121 with Comprehensive Metabolic Lot #8111AA5 , Model Number 400-1028 in polyfoil pouch. Piccolo Comprehensive Metabolic Panel is a single-use self-contained reagent disk, intended for use with the Piccolo and PiccoloXpress chemistry analyzers, for in vitro qualitative determination.
The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples
The firm issued a notification letter to its consignees on April 21, 2008. The firm intends to follow up with phone calls and provide a software upgrade for the products. Contact Abaxis Customer Service at 1-510-675-6500 for assistance.
Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry Analyzer or Piccoloxpress Chemistry Analyzer, Catalog No. 400-0028, manufactured by Abaxis Inc., Union City, CA Medical device for use in the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline Phosphatase (ALP), aspartate aminotransferase, calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, an
Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results.
An "URGENT: PRODUCT RECALL NOTICE" dated November 16, 2009, was sent to customers. The notification described the product, issue/impact, and the action/resolution to be taken by the customers. The customers are to discontinue use of the specified lot, contact Abaxis for immediate replacement and complete and return the enclosed Response form within 5 working days. They may fax the form to Abaxis Technical Support at 1-510-315-3140. The customer are requested to ensure all laboratory staff are informed about this notice and retain this notification as a part of their laboratory Quality System documentation. The firm is currently contacting all direct shipment customers. If you have any questions regarding this Product Recall Notice, please contact Abaxis Medical Technical Support at 800-822-2947, extension 6505, or at medtechsupport@abaxis.com.