Quantikine IVD Erythropoietin Human Serum Controls for use as… — Class III medical device recall Z-1390-2022
Terminated recall by R & D Systems, Inc., reported 2022-07-27, distributed nationwide. The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm contains an err
| Recall number | Z-1390-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | R & D Systems, Inc., Minneapolis, MN, United States |
| Recall initiated | 2022-06-14 |
| Classified | 2022-07-15 |
| Reported by FDA | 2022-07-27 |
| Terminated | 2026-07-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, GB, HK, ID, IL, MX, TH |
| Quantity | 400 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00815762021671 |
| Lot numbers | P301801, P304262, P306132, P310038, P314685, P320216, P322531 |
| Model numbers | 750095 |
| Expiration dates | 2023-08-04 |
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
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1390-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.