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ADVIA Centaur Erythropoietin (EPO) Assay (100 Test) recallZ-1281-2024 · Siemens Healthcare Diagnostics, Inc. · initiated Jan 24, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1281-2024
Status
Open, Classified
Initiated by the company
Jan 24, 2024
Posted by the FDA
Mar 11, 2024
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
264 units (6 US, 258 OUS)
Product code
GGT
FDA submissions
K183088
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 description

ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)

Code information (models, lots, serial numbers)

Siemens Material Number: 10995096; UDI/DI: 00630414010380; Kit Lots: 53984040, 55443042.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K183088 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93939).

Sources and updates

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