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
R&D Systems is recalling Quantikine Erythropoietin Human Serum Controls because the product instructions contain an incorrect CE marking. This labeling error does not affect the product's safety or performance but could cause regulatory compliance issues for users.
The product instructions incorrectly include a Notified Body designation (BSI-2797) for a Class I self-certified product. Under EU regulations, CE-marked Class I products should not have Notified Body designations. This labeling error does not cause physical harm but may lead to regulatory issues.
Users of Quantikine Erythropoietin Human Serum Controls for medical testing are affected. Laboratory professionals using these controls for Erythropoietin concentration testing are most at risk of regulatory non-compliance.
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.
Verify if your Quantikine Erythropoietin Human Serum Controls have the affected lot codes listed in the recall notice.
Reach out to R&D Systems to confirm if your product is affected and request a replacement with the correct labeling.
No, the recall is for a labeling error that does not affect product safety but may cause regulatory compliance issues.
Affected lot codes are P301801, P304262, P306132, P310038, P314685, P320216, and P322531 with expiration date 08/04/2023.
Contact R&D Systems directly to request a replacement with the correct product insert revision 750095.30.
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-1390-2022 — R&D Systems R&D Systems Hello, I own a R&D Systems that is covered by recall Z-1390-2022 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.
