R & D Systems recalls

2 official recalls and safety alerts involving R & D Systems since 2022-07, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with R & D Systems or the relevant agency.

1. 2023-01-25
2. US
   Drugs & medicalClass III

   R & D Systems, Inc. recalls 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…

   For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.

   FDA · DeviceR & D Systems, Inc.Worldwide distribution - US Nationwide distribution in the states of CA, FL,…Official notice →
3. 2022-07-27
4. US
   Drugs & medicalClass III

   R & D Systems, Inc. recalls Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations…

   The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm contains an error associated with product s CE marking. The CE mark contained in the IFU is followed by the Notified Body…

   FDA · DeviceR & D Systems, Inc.Worldwide distribution - US Nationwide distribution in the states of FL, MN,…Official notice →