Reported Jul 27, 2022 · Terminated
Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of…
R & D Systems, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: R & D Systems, Inc. · 614 Mckinley Pl Ne · Minneapolis, MN · 55413-2610
Is this the product you have?
- Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095
- Lot codes and dates
- Lot CodeUDI 00815762021671
- Lot Codes
P301801P304262P306132P310038P314685P320216
- P322531 Expiration Date08/04/2023
- Amount recalled
- 400
Where it was sold
Why it was recalled
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
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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