Recall Z-2237-2021— Advance Dx, Inc.
Class II · Terminated
Class II FDA medical device recall by Advance Dx, Inc., initiated 2021-07-06, terminated 2023-08-22. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Due to high glucose test results when using the blood collection cards..
- Recalling firm
- Advance Dx, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-06
- Terminated
- 2023-08-22
- Firm location
- Scottsdale, AZ, United States
Product description
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
Reason for recall
Due to high glucose test results when using the blood collection cards.
Data sourced from openFDA. This site is unofficial and independent of the FDA.