Z-1280-2024Class II

Atellica IM Erythropoietin (EPO) Assay (100 Test)

Name: Z-1280-2024 Atellica IM Erythropoietin (EPO) Assay (100 Test)
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2024-01-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-01-24 / Open, Classified / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica IM Erythropoietin (EPO) Assay (100 Test) on 2024-01-24. FDA classified it as Class II and gives the reason as "Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1280-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-24
Posted: 2024-03-11
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica IM Erythropoietin (EPO) Assay (100 Test)
Product code: GGT Assay, Erythropoietin
Reason for recall: Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Correction notification letter dated 01/24/24 was sent to customers. Actions to be Taken by the Customer: Discontinue use of and discard the EPO kit lots listed in Table 1. Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. For continued EPO patient testing in your laboratory during this time, please contact your Siemens representative to discuss alternative Siemens Healthineers solutions. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Quantity in commerce: 1,057 units (46 US, 1,011 OUS)
Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, IA, IL, MI, MN, NC, NE, NV, NY, OH and TX; The countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, India, Italy, Japan, Latvia, Malaysia, Netherlands, Norway, P.R. China, Pakistan, Poland, Portugal, Republic of South Korea, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, U.A.E., United Kingdom.
Product codes and lots: Siemens Material Number: 10733006; UDI/DI: 00630414245775; Kit Lots: 53982039, 55439041.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1280-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1280-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-20	2024-03-11
Z-1281-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-20	2024-03-11

Product code GGT

K183088Class IIADVIA Centaur Erythropoietin (EPO) assayAxis-Shield Diagnostics Limited / cleared 2019-08-02

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)