Reported Jan 25, 2023 · Terminated
R&D CBC-3D Hematology Control
R & D Systems, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: R & D Systems, Inc. · 614 Mckinley Pl Ne · Minneapolis, MN · 55413-2610
Is this the product you have?
R&D CBC-3D Hematology Control
28 of 28 products
| Model / number | Barcodes | Product as published |
|---|---|---|
3D501 | (1) CBC-3D Normal Pack Hematology Control, , containing 10 x 2.0mL Control N | |
3D503 | (2) CBC-3D TRI PACK Hematology Control, , containing 4 x 2.0 mL Controls L, N, and H | |
3D503RX | (3) CBC-3D for Mythic 18 Hematology Control, , containing 2 x 2.0 mL each Controls L, N, and H | |
3D506 | (4) CBC-3D For MINDRAY Hematology Control, , containing 2 x 3.0 mL each Controls L, N, and H | |
3D506US | (5) CBC-3D For MINDRAY Hematology Control, , containing 2 x 3.0 mL each Controls L, N, and H | |
3D507 | (6) CBC-3D TRI PACK Hematology Control, , containing 4 x 2.0 mL each Controls L, N, and H | |
3D508 | (7) CBC-3D TRI PACK Hematology Control, , containing 2 x 2.0 m each Controls L, N, and H | |
D3D02 | (8) CBC-3D For ABACUS, Hematology Control, containing 2 x 3.0 mL each Controls L, N, and H | |
AL35004-KIT | (9) CBC-3D For ABACUS Hematology Control, REF D3D04, containing 4 x 3.0 mL each Controls L, N, and H. Loose tubes labeled CBC-3D Hematology Control in 2.0mL and 3.0mL sizes. OEM/Own-label distributor labels: (1) Alere 380 Hemo Control (L-N-H), , containing 2 x 3.0 mL each Controls L, N, and H | |
| — | Kit lot #B1122 | |
HEM00014 | control lot #B1122N, no UDI (2) diatron Diacon 3 Hematology Control, Normal Level, 3.0 mL tubes, lot #B1122N (3) diatron Diacon 3 Hematology Control, REF DN35002-SET, containing 6 x 3.0 mL Control N, kit lot #B1122, control lot #B1122N (4) diatron Diacon 3 Hematology Control, REF DN35004-KIT, containing 2 x 3.0 mL each Controls L, N, and H, kit lot #B1122, Normal control lot #B1122N. (5) Elite 3 HEM Control Normal, , containing 6 x 3.0 mL Normal controls, kit lot #B1122, control lot #B1122N | |
5300000277 | (6) Erba H3 CON N, REF HEM00034, 3 mL vials, lot #E1122N, exp. 2023-02-10 (7) Horiba Medical Minotrol 16 Whole Blood Hematology Control, , containing 3 x 2.5mL tubes (1 each Control 1, Control 2 (Normal), and Control 3 | |
5300000278 | containing 6 x 2.5mL tubes (2 each Control 1, Control 2 (Normal), and Control 3 | |
5300000283 | and , containing 12 x 2.5mL tubes (4 each Control 1, Control 2 (Normal), and Control 3 | |
| — | kit lot #MX438, exp. 2023-01-05, Control 2 lot #MX438N. (8) 2022 3rd Test Event, CBC PLT 3 PART DIFF 2022-912-3D | |
BC3D01 | and 2022 3rd Test Event, CBC PLT 3 PART DIFF 2022-914-3D. (9) mindray BC-3D, P/N 040-001423-00. (10) MINDRAY BC-3D CONTROL, , containing 1 x 3.0 mL Controls L, N, and H | |
BC3D02 | containing 2 x 3.0 mL Controls L, N, and H | |
BC3D6N | and , containing 6 x 3.0 mL Control N | |
3DN03 | kit lot #B1122, control lot #B1122N. (11) MINDRAY BC-3D CONTROL, REF BC3D02US, containing 2 x 3.0 mL Level L, N, and H, kit lot number B1122, control lot #B1122N. (12) Nihon Kohden MEK-3D Hematology Control, , containing MEK-3DN x 3 tubes | |
3DN06 | containing MEK-3DN x 6 tubes |
- Lot codes and dates
32 of 32 products
Products covered by this recall Model / number Barcodes Product as published — 1081576202009100815762020117008157620201240081576202016200815762020179008157620201860081576202023000815762020247Lot B1122, exp. date 2023-02-05; UDI numbers for the following catalog numbers: 3D501 - UDI 10815762020091; 3D503 - UDI 00815762020117; 3D503RX - UDI 00815762020124; 3D506 - UDI N/A OUS only; 3D506US - UDI 00815762020162; 3D507 - UDI 00815762020179; 3D508 - UDI 00815762020186; D3D02 - UDI 00815762020230; and D3D04 - UDI 00815762020247. OEM/Own-label distributor labeled product — lot numbers (Products 1-17) (1) Kit — lot #B1122; control — lot #B1122N. (2) — Lot #B1122N. (3) Kit — lot #B1122, control — lot #B1122N. (4) Kit — lot #B1122, control — lot #B1122N. (5) Kit — lot #B1122, control — lot #B1122N. (6) — Lot #E1122N. (7) Kit — lot #MX438, Control 2 — lot #MX438N. (8) — Lot #2022-912-3D and — Lot #2022-914-3D. (9) 040-001423-00.(10) Kit — lot #B1122, control — lot #B1122N. (11) Kit — lot number B1122, control - Amount recalled
- 8,259 kits, 28,136 labeled loose tubes, and 15,926 unlabeled loose tubes
Where it was sold
Why it was recalled
For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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