Z-2237-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 18, 2021
- Initiation Date
- July 6, 2021
- Termination Date
- August 22, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 179,750 cards
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.
Distribution Pattern
U.S. Nationwide distribution in the states of MD and NC.
Code Information
Product Catalog Number: CMT01 GTIN: 1061C010890976 Lot Number: PPD02102 V6