Lower riskMedical device recall · FDA · Published June 14, 2022
R&D Systems Quantikine Erythropoietin Controls Recall: CE Marking Error
R&D Systems recalls Quantikine Erythropoietin Human Serum Controls due to incorrect CE marking in product instructions. Affected lots have a labeling error that may cause regulatory issues but does not pose a safety risk to users.
The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm contains an error associated with product s CE marking. The CE mark contained in the IFU is followed by the Notified Body designation, British Standards Institution number 2797 (BSI-2797) for product inserts 750095.28 and 750095.29. The erroneous label CE2797 were in the IFU insert revision 750095.28 for the 408 affected lots that were shipped. No product was packed with erroneous insert revision 750095.29. Since the product is currently CE marked as a Class I - self-certified product under the EU In Vitro Diagnostics Directive, the Notified Body designation should not be specified. As part of the corrective action, the firm has notified the customers who received the products with erroneous labeling, and is conducting the replacements with the correct product insert containing the Insert Revision 750095.30
Take action
Contact the company
📍Recalling firmR & D Systems, Inc.614 Mckinley Pl Ne · Minneapolis, MN 55413-2610
“R&D Systems Quantikine Erythropoietin Controls Recall: CE Marking Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60510-r-d-systems-quantikine-erythropoietin-controls-recall-ce-marking-error. Based on FDA recall #Z-1390-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1390-2022%22&limit=1).
The FDA announced on June 14, 2022, that R&D Systems is recalling Quantikine IVD Erythropoietin Human Serum Controls due to an error in the Instructions for Use regarding CE marking. The agency said the firm has notified customers and is replacing the products with correct inserts.
How to tell if you have it
Brand: R&D Systems
Product: Quantikine IVD Erythropoietin Human Serum Controls
IFU Part Number: 750095
Lot Codes: P301801, P304262, P306132, P310038, P314685, P320216, P322531
Expiration Date: 08/04/2023
The hazard
The Instructions for Use provided with the affected lots contains an error associated with the product's CE marking. The erroneous label included a Notified Body designation that should not be specified for this Class I self-certified product under the EU In Vitro Diagnostics Directive.
Context
GovInfoNow's records show R & D Systems, Inc. has 4 other recalls on record since 2018-09-11. Other recent recalls of similar products include Boston Scientific FARASTAR Ablation Generator EU Recall (2026-06-11), Fresenius Medical Care Bicarby Dialysate Recall (2026-05-07), and Edwards EVOQUE Tricuspid Delivery System Recall (2026-03-27).
How to tell if you have this one
Check if your Quantikine Erythropoietin Human Serum Controls have the lot codes P301801, P304262, P306132, P310038, P314685, P320216, or P322531 with expiration date 08/04/2023. The product is labeled with an incorrect CE marking in the instructions.
Brand
R&D Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Verify if your Quantikine Erythropoietin Human Serum Controls have the affected lot codes listed in the recall notice.
Contact Manufacturer
Reach out to R&D Systems to confirm if your product is affected and request a replacement with the correct labeling.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 11 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of FL, MN, UT, OH, MA, TX, PR, PA, NJ, CA, WI, LA, Puerto Rico, and the countries of CANADA, UNITED KINGDOM, ISRAEL, MEXICO, THAILAND, CHINA, HONG KONG, AUSTRALIA, INDONESIA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Louisiana, Massachusetts, Minnesota, New Jersey, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, Wisconsin.
Recall timeline
FDA terminated this recall 4.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1390-2022 (June 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1390-2022 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.