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U.S. Department of Health and Human Services

Class 2 Device Recall Emerald Diluent Tubing

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  Class 2 Device Recall Emerald Diluent Tubing see related information
Date Initiated by Firm May 09, 2019
Create Date October 22, 2019
Recall Status1 Terminated 3 on October 07, 2020
Recall Number Z-0173-2020
Recall Event ID 83793
510(K)Number K081495  
Product Classification Counter, differential cell - Product Code GKZ
Product Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.
Code Information Tubing lot #2018-10-16; Instrument serial numbers 007689, 007690, 007691, 007692, 007705, 007706, 007707, 007708, 007709, 007728, 007694, 007695, 007697, 007766, 007767, 007768, 007765, 007710, 007699, 007700, 007701, and 007703. 
Recalling Firm/
Manufacturer		 Abbott Laboratories
4551 Great America Pkwy
Santa Clara CA 95054-1208
For Additional Information Contact Mr. Albert Chianello
877-422-2688
Manufacturer Reason
for Recall		 The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The recalling firm issued letters on 5/9/2019 to the consignees who had the installed instruments with the affected serial numbers. The letters were issued via FedEx priority overnight express.
Quantity in Commerce 22 analyzers with tubing
Distribution Distribution was made to GA, LA, MA, NC, NY, SC, and TX. There was no military/government distribution. Foreign distribution was made to Australia, Germany, Greece, Honduras, Indonesia, Italy, and Serbia.
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 = GKZ and Original Applicant = ABBOTT LABORATORIES
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