R&D Systems recalls CBC-3D Hematology Controls (lot B1122) with potential microbial contamination causing hemolysis. Affected products include various control kits for hematology analyzers.
For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.
R&D Systems is recalling CBC-3D Hematology Control products that may have microbial contamination leading to hemolysis. This could cause inaccurate test results or potential health risks if used in medical devices.
The recalled CBC-3D Hematology Controls may contain microbial contamination that causes hemolysis (rupture of red blood cells) or deterioration. This could lead to inaccurate blood test results if used in hematology analyzers.
Healthcare professionals and labs using CBC-3D Hematology Controls with lot numbers B1122 or control lots B1122N are most at risk. Patients using these controls in medical testing may be affected if the controls cause inaccurate results.
Check for product lot numbers B1122 or control lots B1122N on the packaging. Products include CBC-3D Normal Pack (REF 3D501), CBC-3D TRI PACK (REF 3D503), and other variants labeled for specific analyzers like MINDRAY or ABACUS.
Look for lot numbers B1122 or control lots B1122N on the packaging or labels of the CBC-3D Hematology Controls.
The recall includes CBC-3D Hematology Controls with lot numbers B1122 or control lots B1122N, such as REF 3D501 (Normal Pack), REF 3D503 (TRI PACK), and various OEM-labeled products like Alere 380 Hemo Control and diatron Diacon 3 Hematology Controls.
The recalled products may have microbial contamination causing hemolysis or deterioration, which could lead to inaccurate blood test results if used in hematology analyzers.
Check the product lot number and control lot number on the packaging. If they match B1122 or B1122N, contact the manufacturer or your lab supplier for guidance on disposal or replacement.
We’ve drafted a message you can send R&D Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0999-2023 — R&D Systems R&D Systems Hello, I own a R&D Systems that is covered by recall Z-0999-2023 from R&D Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
