—#205973

Product

Atellica IM Erythropoietin (EPO) Assay (100 Test)

FDA product code: GGT — Assay, Erythropoietin
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K183088
Affected lot / code info: Siemens Material Number: 10733006; UDI/DI: 00630414245775; Kit Lots: 53982039, 55439041.

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-01-24
Posted by FDA: 2024-03-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205973. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.