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Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of… recallZ-0830-2020 · Siemens Healthcare Diagnostics, Inc · initiated Jul 22, 2019

Class II Terminated All recalls posted in January 2020

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

Homocysteine Assay May Cause Elevated Results in the Folate Assay

FDA root cause category: Device Design

What the company is doing

Siemens issued Urgent Medical Device Correction, CC 19-07.A.US to customers on July 22, 2019 to be delivered to customers on July 23, 2019. After release of the letter (CC 19-07.A.US), we identified a typographical error in Table 1, specifically the Reference kit SMN (19331250). Version B (CC 19-07-B.US) is being created with the corrected SMN Number (10331250) and distributed to the reference accounts that order SMN (Quest Diagnostics). Urgent Field Safety Notice, CC 19-07.A.OUS was sent out to the country organizations on July 19, 2019 for distribution to customers outside the United States. The customer distribution included all customers that have received both ADVIA Centaur Folate and ADVIA Centaur Homocysteine over the past year. The letters inform customers the potential for the ADVIA Centaur Homocysteine assay to cause elevated Folate results when an ADVIA Centaur Folate test immediately follows an ADVIA Centaur Homocysteine test. The communications provide recommendations to run the assays on different ADVIA Centaur systems or on other Siemens Healthcare systems or to test all Homocysteine samples together followed by the Daily Cleaning Procedure prior to testing the Folate assay to mitigate the interference. Field Correction Effectiveness Check form provided. Questions contact your Siemens Customer Care Center or your local Siemens technical support representative. Update: 11/30/20 Siemens issued Follow Up Customer Notification CC 19-07.C.US and or CC 19-07.B.OUS, dated Dec.1, 2020 via overnight to US customers on December 1st, 2020 and Siemens EU Authorized Representatives issued the letter to OUS countries on December 1st, 2020, stating:Siemens has implemented a new wash mitigation into ADVIA Centaur XPT Folate (FOL) Test Definition (TDef) Version 2.1 and ADVIA Centaur XPT Homocysteine (HCY) TDef Version 1.5 for use on the ADVIA Centaur XPT system and TDef Version EL/EM on the ADVIA Centaur XP system. Actions to be Taken by the Custome

Recall details

Recall number
Z-0830-2020
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 22, 2019
Posted by the FDA
Jan 21, 2020
Recalling firm
Siemens Healthcare Diagnostics, Inc
Quantity
10,928 kits
Product code
CGN
FDA submissions
K010050
Distribution
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Product description

Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366

Code information (models, lots, serial numbers)

All lots

Other devices under the same FDA submission

3 devices cleared under K010050 — the recall does not name any of them by identifier. 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 84078).

Sources and updates

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