R&D CBC-3D Hematology Control Recalled for Potential Microbial Contamination
R&D Systems is recalling one lot of CBC-3D Hematology Control due to potential microbial contamination that may cause hemolysis or deterioration in the Normal control level.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III classification with no reported illnesses or injuries. The hazard is potential microbial contamination in a laboratory control material, representing a risk to testing operational integrity rather than direct patient harm. This fits the criteria for low-risk contamination in a precautionary recall.
Plain-English summary
R&D Systems, Inc. is recalling one lot (B1122) of CBC-3D Hematology Control and its OEM-labeled variants due to potential microbial contamination. The affected control material may exhibit hemolysis or deterioration in the Normal level, which could compromise the accuracy of laboratory hematology test results.
The recalled product was distributed worldwide, including to customers in the United States (California, Florida, Georgia, Iowa, Kentucky, Louisiana, Massachusetts, Missouri, North Carolina, New Jersey, New York, Ohio, Texas, and Puerto Rico), Brazil, China, Costa Rica, Czech Republic, France, Germany, Great Britain, Honduras, Hungary, Indonesia, Israel, Japan, Kuwait, Mexico, Netherlands, Nicaragua, Panama, Peru, Poland, Romania, El Salvador, South Africa, South Korea, Switzerland, Thailand, Turkey, and Vietnam. The recall includes 8,259 kits, 28,136 labeled loose tubes, and 15,926 unlabeled loose tubes under various product codes and distributor labels.
Laboratories using the affected lot should discontinue use of the contaminated control material and contact R&D Systems or their distributor for a replacement. Laboratory professionals should verify their control materials are not from the affected lot by checking the lot number against the recall information.
The recalled product
- Product
- 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,
- Manufacturer
- R & D Systems, Inc.
- Hazard
- microbial-contamination
- product-deterioration
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
- 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 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
Distribution
Distributed nationwide across the United States.
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