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

Hazard

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

Details from the source

Reason for recall: For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination. 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, Netherlands, Nicaragua, Panama, Peru, Poland, Romania, San Salvador, South Africa, South Korea, Switzerland, T Quantity: 8,259 kits, 28,136 labeled loose tubes, and 15,926 unlabeled loose tubes 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;

UPC codes

10815762020091, 00815762020117, 00815762020124, 00815762020162, 00815762020179, 00815762020186, 00815762020230, 00815762020247, 00630414600833

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.