Erythropoietin Control Product Instructions Contain Incorrect CE Marking
R & D Systems is replacing Instructions for Use (IFU) for Quantikine IVD Erythropoietin Human Serum Controls due to an incorrect CE marking designation that should not appear on the self-certified product.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a FDA Class III documentation error with no reported safety issues. The error appears only in the Instructions for Use labeling regarding the CE marking designation. No product functionality or patient safety is affected, consistent with the rubric criterion for documentation issues.
Plain-English summary
R & D Systems, Inc. is recalling Instructions for Use (IFU, Part Number 750095) distributed with Quantikine IVD Erythropoietin Human Serum Controls. These are laboratory control materials used to verify test results when measuring erythropoietin concentrations in human serum and plasma samples. The affected Instructions for Use were distributed with products bearing lot codes including P301801, P304262, P306132, P310038, P314685, P320216, P322531, with an expiration date of August 4, 2023.
The IFU contains a labeling error regarding the product's CE marking. Specifically, the CE mark is followed by the Notified Body designation BSI-2797 (British Standards Institution number 2797), which should not appear on this product. The product is classified as a self-certified Class I device under the European Union's In Vitro Diagnostics Directive and does not require a Notified Body designation on its labeling.
Approximately 408 units with the erroneous IFU were distributed worldwide. Distribution included customers in the United States (Florida, Minnesota, Utah, Ohio, Massachusetts, Texas, Puerto Rico, Pennsylvania, New Jersey, California, Wisconsin, Louisiana) and internationally in Canada, United Kingdom, Israel, Mexico, Thailand, China, Hong Kong, Australia, and Indonesia.
R & D Systems has notified customers who received products with the erroneous labeling and is conducting replacements with corrected Instructions for Use (Insert Revision 750095.30). The product itself is not defective and functions as intended; only the labeling of the Instructions for Use contained the error.
The recalled product
- Product
- 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
- Manufacturer
- R & D Systems, Inc.
- Hazard
- Affected units
- 400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot Code: UDI 00815762021671
- Lot Codes: P301801
- P304262
- P306132
- P310038
- P314685
- P320216
- P322531 Expiration Date: 08/04/2023
Distribution
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