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U.S. Department of Health and Human Services

Class 2 Device Recall Advance Dx100 Serum Separator Blood Collection Card

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  Class 2 Device Recall Advance Dx100 Serum Separator Blood Collection Card see related information
Date Initiated by Firm July 06, 2021
Create Date August 10, 2021
Recall Status1 Terminated 3 on August 22, 2023
Recall Number Z-2237-2021
Recall Event ID 88281
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01

Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02

IFU:
Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS
Code Information Product Catalog Number: CMT01 GTIN: 1061C010890976 Lot Number: PPD02102 V6
Recalling Firm/
Manufacturer		 Advance Dx, Inc.
11250 N 118th Way
Scottsdale AZ 85259-4149
For Additional Information Contact
877-239-1001
Manufacturer Reason
for Recall		 Due to high glucose test results when using the blood collection cards.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 06/15/2021, the firm sent an initial customer notification via email and on 07/06/2021 follow up email was sent with a revised "FOLLOW-UP URGENT: MEDICAL DEVICE RECALL" Letter. The notification was to inform customers that blood collection cards manufactured in 2020 provided inaccurate blood glucose values. Customers are instructed to: 1. If they are conducting blood glucose testing with the affected Blood Collection Card, immediately STOP and review their inventory and remove them from all inventory locations. Recalled products can be identified by the Lot number printed on the products packaging and shipper containers. 2. Pass on this information to anyone who uses or orders Blood Collection Cards at their facility. Additionally, ensure that a copy of this letter is provided to any other organizations to which affected devices have been transferred. 3. Complete the Customer Recall Response Card, scan and email immediately to the email address on the Customer Recall Response Card for product in your facility at the time of receipt of this letter. 4. The Recalling Firm is working to ensure that replacement products are readily available. Once customers have identified how much product they will be returning, call Recalling Firm's Customer Service at 1-847-677-3823 to arrange for product replacement. Any questions concerning this product recall, contact Director of Regulatory Affairs/Quality Assurance at 1-949-433-3058 between 8:00 AM and 5:00 PM Pacific Standard Time, Monday-Friday.
Quantity in Commerce 179,750 cards
Distribution U.S. Nationwide distribution in the states of MD and NC.
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.
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