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Atellica CH 2-Microglobulin (B2M) -M) Assay for in vitro… recallZ-0440-2022 · Siemens Healthcare Diagnostics, Inc. · initiated Dec 1, 2021

Terminated

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

2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on patient samples of up to -10.5% at a B2M concentration of approximately 15 mg/L

FDA root cause category: Under Investigation by firm

What the company is doing

Siemens issued An Urgent Medical Device Correction (UMDC) letter to US customers by FedEx beginning on 2021-12-01. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities beginning on 2021-12-01. Letter states reason for recall, health risk and action to take: Discontinue use of and discard the kit lot listed in Table 1. Review your inventory of this product to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the product 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. If you have any questions, contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.

Recall details

Recall number
Z-0440-2022
Status
Terminated
Initiated by the company
Dec 1, 2021
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
US: 46 units OUS: 794 units
Product code
JZG
Distribution
Worldwide distribution - US Nationwide distribution in the states of CA, CO, MA, MD, MS, NC, NE, NH, OH, VA, WI and the countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Czech Republic, Denmark, Ecuador, France, Germany, Greece, India, Iran, Israel, Italy, Japan, Mexico, Morocco, Oman, P.R. China, Pakistan, Philippines, Portugal, Slovakia, South Africa, Spain, Switzerland, Turkey, United Kingdom, Uruguay.

Product description

Atellica CH 2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of 2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635

Code information (models, lots, serial numbers)

Lot Number: 211446 UDI: 00630414595566

Devices named in this recall

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

Sources and updates

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