R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N;

Summary

The FDA issued a Class III for R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF by R & D Systems, Inc.. Reason: For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination..

Details

Product Description

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 each Controls L, N, and H; (5) CBC-3D For MINDRAY Hematology Control, REF 3D506US, containing 2 x 3.0 mL each Controls L, N, and H; (6) CBC-3D TRI PACK Hematology Control, REF 3D507, containing 4 x 2.0 mL each Controls L, N, and H; (7) CBC-3D TRI PACK Hematology Control, REF 3D508, containing 2 x 2.0 m each Controls L, N, and H; (8) CBC-3D For ABACUS, REF D3D02 Hematology Control, containing 2 x 3.0 mL each Controls L, N, and H; (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), REF AL35004-KIT, containing 2 x 3.0 mL each Controls L, N, and H; Kit lot #B1122; 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, REF HEM00014, containing 6 x 3.0 mL Normal controls, kit lot #B1122, control lot #B1122N; (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, Cat. #5300000277, containing 3 x 2.5mL tubes (1 each Control 1, Control 2 (Normal), and Control 3; Cat. #5300000278, containing 6 x 2.5mL tubes (2 each Control 1, Control 2 (Normal), and Control 3; and Cat. #5300000283, 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; 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, REF BC3D01, containing 1 x 3.0 mL Controls L, N, and H; REF BC3D02, containing 2 x 3.0 mL Controls L, N, and H; and REF BC3D6N, containing 6 x 3.0 mL Control N; 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, REF 3DN03, containing MEK-3DN x 3 tubes; REF 3DN06, containing MEK-3DN x 6 tubes; and REF 3DN12, containing MEK-3DN x 12 tubes, kit lot #B22Y, control lot #B22YN. (13) Nihon Kohden MEK-3DN Normal Hematology Control tubes, 2.0 mL, lot #B22YN. (14) Orphee MYT-3D, REF MYT301, containing 2 x 2.5 mL Control N; REF MYT302, containing 2 x 2.5 mL each Controls L, N, and H; REF MYT304N, containing 4 x 2.5 mL Control N; REF 306N, containing 6 x 2.5 mL Control N; kit lot #B1122, control lot #B1122N; Myt-3D VET, REF MYT303-VET, containing 1 x 2.5 mL each Control L, N, and H. (15) Siemens ADVIA 360 Control, REF 11170853, containing 2 x 3.0 mL each Controls Low, Normal & High, kit lot #B0822, GTIN 00630414600833, control lot #B1122N. (16) URIT HQ-3DIFF, REF 5411000306, containing 2 x 3.0 mL each Controls L, N, and H, kit lot #B1122, control lot #B1122N; URIT HQ-3DIFF Hematology Control N tubes, 3.0 mL, lot #B1122N. (17) Woodley Haematology Control, REF WD1154, containing 6 x 2.0 mL Control N; and REF WD1154A, containing 2 x 2.0 mL each Controls L, N, and H, kit lot number B1122, control lot #B1122N;

Lot/Code Info: R&D labeled product lot numbers: (Products 1-9): Lot 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) P/N 040-001423-00. (10) Kit lot #B1122, control lot #B1122N. (11) Kit lot number B1122, control lot #B1122N. (12) Kit lot #B22Y, control lot #B22YN. (13) Lot #B22YN. (14) Kit lot #B1122, control lot #B1122N. (15) Kit lot #B0822, GTIN 00630414600833, control lot #B1122N. (16) Kit lot #B1122, control lot #B1122N. (17) Kit lot number B1122, control lot #B1122N;

Quantity Affected: 8,259 kits, 28,136 labeled loose tubes, and 15,926 unlabeled loose tubes

Reason for Recall

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

Type: Voluntary: Firm initiated

Recall Initiated: 2022-11-07

Company