FDA Medical Device Recalls (openFDA)
Advance Dx, Inc.: 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
- Recall number
- Z-2237-2021
- Recalling firm
- Advance Dx, Inc.
- 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
- Status
- Terminated
- Initiated
- 2021-07-06
- Posted
- not on file
- Terminated
- 2023-08-22
- Reason
- Due to high glucose test results when using the blood collection cards.
- Root cause
- 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
- 179,750 cards
- Distribution
- U.S. Nationwide distribution in the states of MD and NC.
- Lot, serial or model codes
- Product Catalog Number: CMT01 GTIN: 1061C010890976 Lot Number: PPD02102 V6
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 3006457763
- Firm city
- Scottsdale
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28