R & D Systems, Inc. recalls Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoi…

Recall date

June 14, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1390-2022

FDA classification

Class III

Brand / firm

R & D Systems, Inc.

Sold / distributed

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.

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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