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
Check against the official notice below — it lists the full affected range.
R & D Systems, Inc. is recalling Quantikine IVD Erythropoietin Human Serum Controls due to an error in the Instructions for Use (IFU, Part Number 750095). The product insert revision 750095.28 included an incorrect CE marking that displayed a Notified Body designation (BSI-2797) when the product is actually CE marked as a Class I self-certified product under the EU In Vitro Diagnostics Directive and should not have a Notified Body designation specified. The error affected 408 lots shipped worldwide, including distribution in multiple U.S. states and several countries including Canada, United Kingdom, Mexico, China, Australia, and others. The affected lots can be identified by the UDI code 00815762021671 and specific lot codes including P301801, P304262, P306132, P310038, P314685, P320216, and P322531 with an expiration date of 08/04/2023.
As part of its corrective action, the firm has already notified customers who received products with the erroneous labeling and is conducting replacements with the correct product insert revision 750095.30. The source document does not specify what an affected consumer should do beyond noting that the firm has initiated customer notification and replacement efforts.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 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. Quantity: 400 Lot/code info: Lot Code: UDI 00815762021671, Lot Codes: P301801; P304262; P306132; P310038; P314685; P320216; P322531 Expiration Date: 08/04/2023
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.