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Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product… recallZ-0722-2021 · Siemens Healthcare Diagnostics, Inc. · initiated Nov 23, 2020

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

Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) listed in the Instructions For Use (IFU) on some analyzers.

FDA root cause category: Device Design

What the company is doing

Siemens Healthcare Diagnostics Urgent Field Safety Notice letter beginning November 23, 2020 via Fed Ex and outside the US the distribution is determined at the country level. Letter states reason for recall , health risk and action to take: For the product listed above, please perform the following steps: 1. Review and apply the preliminary precision performance characteristics of d8% CV at a GGT concentration of approximately 27 U/L 42 U/L provided. 2. Please review this letter with your Medical Director. 3. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. 4. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Contact your Siemens Customer Care Center or your local Siemens technical support representative. The precision section of the IFUs will be updated when the investigation is complete. The updated IFUs will be uploaded into Document Library where all registered users who opt in to receive alerts will be notified of the updated IFU.

Recall details

Recall number
Z-0722-2021
Status
Open, Classified
Initiated by the company
Nov 23, 2020
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
731 units US; 16824 units OUS
Product code
JQA
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Australia, Austria, Bahamas, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, India, Iran, Ireland, Israel, Italy, Japan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Philippines, Poland, Portugal, Qatar, Republic Korea, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, Uruguay, Vatican City, Vietnam. ¿¿¿¿ ¿¿¿¿¿

Product description

Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): 11097597

Code information (models, lots, serial numbers)

All lot codes. UDI: 00630414596440

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 86900).

Sources and updates

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