Z-1390-2022Class III

Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of...

Name: Z-1390-2022 Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of...
Creator: R & D Systems, Inc.
Published: 2022-06-14
License: https://open.fda.gov/license/

R & D Systems, Inc. / initiated 2022-06-14 / Completed / root cause: manufacturing process

FDA source

R & D Systems, Inc. began a recall of Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and... on 2022-06-14. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1390-2022
Classification: Class III
Status: Completed
Initiated: 2022-06-14
Posted: 2022-07-15
Recalling firm: R & D Systems, Inc.
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
Product code: GGT Assay, Erythropoietin
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm notified its consignees on 06/14/2022 by email. Distributors were directed to notify their customers. Users were directed to destroy any inventory.
Quantity in commerce: 400
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.
Product codes and lots: Lot Code: UDI 00815762021671, Lot Codes: P301801; P304262; P306132; P310038; P314685; P320216; P322531 Expiration Date: 08/04/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1390-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1390-2022	Class III	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-15

Product code GGT

K931756Class IIQuantikine(tm) Erythropoietin Human Serum ControlsR&D Systems, Inc. / cleared 1994-04-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)