Advance Dx, Inc. Recall 88281
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
Advance Dx, Inc. Recall 88281 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2237-2021 |
| Event ID | 88281 |
| Event 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 |
| Product Type | Devices |
| Distribution | U.S. Nationwide distribution in the states of MD and NC. |
| Quantity | 179,750 cards |
| Recall Reason | Due to high glucose test results when using the blood collection cards. |
| Device Classification | 20210818 |
| Device Code Info | Product Catalog Number: CMT01 GTIN: 1061C010890976 Lot Number: PPD02102 V6 |
| Center Classification Date | 20210810 |
| Recall Initiation Date | 20210706 |
| Recalling Firm | Advance Dx, Inc. |
| Initial Notification | Letter |
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