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Atellica IM Fol recallZ-1151-2023 · Siemens Healthcare Diagnostics, Inc. · initiated Jan 9, 2023

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

Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

FDA root cause category: Under Investigation by firm

What the company is doing

Siemens Healthineers issued Urgent Medical Device Corrections (UMDC AIMC 23-03.A-1.US and AIMC 23-03.A-2.US) to US customers and Urgent Field Safety Notices (UFSN AIMC 23-03.A-1.OUS and AIMC 23-03.A-2.OUS) to customers outside the United States. The UMDCs and UFSNs advise customers to use the appropriate FolSerum calibration instructions when testing serum samples with Atellica IM Folate kit lots ending in 337 and above or ADVIA Centaur Folate kit lots ending in 336 and above. Letter states reason for recall, health risk and action to take: Follow the instructions in this Urgent Medical Device Correction until the Atellica IM Folate/ADVIA Centaur Folate Instructions for Use are updated. o Before updating to the new reagent lot, ensure you have processed all serum samples necessary for lot-to-lot comparisons using your existing inventory. o Once you have updated to the new reagent lot, you will not be able to process serum samples with the previous reagent lot. o If your laboratory runs both serum and whole blood sample types, then both assays must be calibrated with the new reagent lot. o If your laboratory runs one sample type, only calibrate the sample type you use 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-1151-2023
Status
Open, Classified
Initiated by the company
Jan 9, 2023
Posted by the FDA
Feb 21, 2023
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
1,865 kits
Product code
CGN
FDA submissions
K172201
Distribution
Nationwide Foreign: Albania¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Bulgaria¿¿¿¿¿¿¿ Croatia¿¿¿¿¿¿¿¿ Cura¿ao,¿St¿Eus Cyprus¿¿¿¿¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Estonia¿¿¿¿¿¿¿¿ Finland¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Hungary¿¿¿¿¿¿¿¿ Iran¿¿¿¿¿¿¿¿¿¿¿ Ireland¿¿¿¿¿¿¿¿ Israel¿¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Jordan¿¿¿¿¿¿¿¿¿ Kenya¿¿¿¿¿¿¿¿¿¿ Latvia¿¿¿¿¿¿¿¿¿ Lithuania¿¿¿¿¿¿ Malta¿¿¿¿¿¿¿¿¿¿ Morocco¿¿¿¿¿¿¿¿ Nepal¿¿¿¿¿¿¿¿¿¿ Netherlands¿¿¿¿ Norway¿¿¿¿¿¿¿¿¿ Oman¿¿¿¿¿¿¿¿¿¿¿ Pakistan¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Qatar¿¿¿¿¿¿¿¿¿¿ Romania¿¿¿¿¿¿¿¿ Saudi¿Arabia¿¿¿ Serbia¿¿¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Slovenia¿¿¿¿¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Sweden¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ Tunisia¿¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿ U.A.E.¿¿¿¿¿¿¿¿¿ Uganda¿¿¿¿¿¿¿¿¿ Ukraine¿¿¿¿¿¿¿¿ United¿Kingdom¿ Vatikancity¿¿¿¿ Country AR AU BR BS CA CL CN CO CR DO EC HK IL IN JP KR MX MY NZ PE PH PY SA SG TH TW UY VN ZA

Product description

Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 11206252

Code information (models, lots, serial numbers)

UDI: (01)00630414293653(10)16097337(17)20230320 (01)00630414293653(10) 44861343 (17)20230630 (01)00630414293653(10) 63869345 (17)20230726 Lot Numbers: 16097337, 44861343, 63869345 and higher. Affects all current and future lots of the Atellica IM Folate assay until the Instructions for Use are updated.

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

2 devices cleared under K172201 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 91522).

Sources and updates

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