Recall Z-2237-2021 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Advance Dx, Inc.
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
| Date | Jul 6, 2021 |
| Status | Terminated |
| Reason | Due to high glucose test results when using the blood collection cards. |
| 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 product |
| Quantity | 179,750 cards |
| Distribution | U.S. Nationwide distribution in the states of MD and NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.