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U.S. Department of Health and Human Services

Class 2 Device Recall Piccolo MetLyte 7 Reagent Disc

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  Class 2 Device Recall Piccolo MetLyte 7 Reagent Disc see related information
Date Initiated by Firm April 21, 2008
Date Posted September 17, 2008
Recall Status1 Terminated 3 on April 26, 2011
Recall Number Z-2287-2008
Recall Event ID 48709
510(K)Number K992140  
Product Classification Reagent Disc - Product Code JLB
Product Piccolo Chemistry Analyzer software version 6.121 with Electrolyte Panel Lot #8041AC5, model number 400-1022 in polyfoil pouch. Piccolo Electrolyte Panel is a single-use, self-contained reagent disk intended for use with the Piccolo and PiccoloXpress chemistry analyzers, for in vitro qualitative determination.
Code Information software version 6.121 with Electrolyte Panel Lot #8041AC5, expiration date 2009-01-21
Recalling Firm/
Manufacturer		 Abaxis Inc
3240 Whipple Rd
Union City CA 94587
For Additional Information Contact
510-675-6500
Manufacturer Reason
for Recall		 The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 237 kits
Distribution Product was distributed Worldwide.
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 = JLB and Original Applicant = ABAXIS, INC.
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