Recall Z-0999-2023 ยท JPK Mixture, Hematology Quality Control
R & D Systems, Inc.
R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N; (2) CBC-3D TRI PACK Hematology Control, REF 3D503, containing 4 x 2.0 mL Controls L, N, and H; (3) CBC-3D for Mythic 18 Hematology Control, REF 3D503RX, containing 2 x 2.0 mL each Controls L, N, and H; (4) CBC-3D For MINDRAY Hematology Control, REF 3D506, containing 2 x 3.0 mL
| Date | Jan 19, 2023 (initiated Nov 7, 2022) |
| Status | Terminated |
| Reason | For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued letters to their OEM/own-label distributor (OLD) customers on 11/7/2022 via email. The letter informed the OEM/OLD of the issue, requested they inspect the Normal Level control for signs of hemolysis or deterioration, and to discard the tubes if hemolysis or deterioration are noted. They are to sign and return the Acknowledgement and Receipt form via email by 12/2/2022. The letter informs the OEM/OLD that a new lot of CBC-3D Normal Level Hematology Control will be available 1/9/2023. The letter did not request them to notify their customers. Updated OEM/OLD lette |
| Quantity | 8,259 kits, 28,136 labeled loose tubes, and 15,926 unlabeled loose tubes |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CA, FL, GA, IA, KY, LA, MA, MO, NC, NJ, NY, OH, TX and Puerto Rico. The countries of Brazil, China, Costa Rica, Czech Republic, France, Germany, Great Britain, Honduras, Hungary, Indonesia, Israel, Japan, Kuwait, Mexico, Netherland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K843962 | CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE R&D Systems, Inc., Nov 1, 1984 |