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

Recall Insight

This FDA Devices action (record #Z-1390-2022) was formally reported on July 27, 2022, with the manufacturer initiating the action on June 14, 2022. It is classified under Low severity (Class III), with a current status of Ongoing. R & D Systems, Inc. is listed as the recalling firm, operating out of Minneapolis, MN. Federal records indicate 400 units are affected.

The documented reason for this recall is: 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 de… Distribution data in the federal record shows the product reached: 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, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.