Device 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
Z-2237-2021
Product summary
- Firm
- Advance Dx, Inc.
- Event
- Event 88281
- Status
- Terminated
- Classification
- Class II
- Quantity
- 179,750 cards
- Official record key
device-enforcement:Z-2237-2021
Official wording
Reason: Due to high glucose test results when using the blood collection cards.
Code information: Product Catalog Number: CMT01 GTIN: 1061C010890976 Lot Number: PPD02102 V6
Distribution pattern: U.S. Nationwide distribution in the states of MD and NC.
Derived failure modes
-
Unknown
Due to high glucose test results when using the blood collection cards.