Date Initiated by Firm | April 21, 2008 |
Date Posted | September 17, 2008 |
Recall Status1 |
Terminated 3 on April 26, 2011 |
Recall Number | Z-2286-2008 |
Recall Event ID |
48709 |
510(K)Number | K992140 |
Product Classification |
Reagent Disc - Product Code JLB
|
Product | Piccolo Chemistry Analyzer software version 6.121 with 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. |
Code Information |
software version 6.121 with Comprrehensive Metabolic Lot #8111AA5, expiration date 2009-03-10 |
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 | 893 kits |
Distribution | Product was distributed Worldwide. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JLB
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