Z-2237-2021Class II

Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags...

Name: Z-2237-2021 Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags...
Creator: Advance Dx, Inc.
Published: 2021-07-06
License: https://open.fda.gov/license/

Advance Dx, Inc. / initiated 2021-07-06 / Terminated / root cause: manufacturing process

FDA source

Advance Dx, Inc. began a recall of 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... on 2021-07-06. FDA classified it as Class II and gives the reason as "Due to high glucose test results when using the blood collection cards". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2237-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-06
Posted: 2021-08-10
Terminated: 2023-08-22
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
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Due to high glucose test results when using the blood collection cards.
Root cause tag: manufacturing process
FDA 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 in commerce: 179,750 cards
Distribution: U.S. Nationwide distribution in the states of MD and NC.
Product codes and lots: Product Catalog Number: CMT01 GTIN: 1061C010890976 Lot Number: PPD02102 V6

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2237-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2237-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-10

Product code JKA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)