R&D Systems Recalls CBC-3D Hematology Controls Due to Microbial Contamination Risk
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.
Lower-risk recall
For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/59491-r-d-systems-recalls-cbc-3d-hematology-controls-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/59491-r-d-systems-recalls-cbc-3d-hematology-controls-due-to · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0999-2023
Cite this page
“R&D Systems Recalls CBC-3D Hematology Controls Due to Microbial Contamination Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59491-r-d-systems-recalls-cbc-3d-hematology-controls-due-to. Based on FDA recall #Z-0999-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0999-2023%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
R&D Systems- Product
R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N- Category
Medical device
What to do — step by step
Check Product Lot Numbers
Look for lot numbers B1122 or control lots B1122N on the packaging or labels of the CBC-3D Hematology Controls.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 13 states.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Georgia, Iowa, Kentucky, Louisiana, Massachusetts, Missouri, New Jersey, New York, North Carolina, Ohio, Puerto Rico, Texas.
Recall timeline
FDA terminated this recall 3.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0999-2023 (November 7, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0999-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.