Date Initiated by Firm | January 09, 2023 |
Date Posted | February 21, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1151-2023 |
Recall Event ID |
91522 |
510(K)Number | K172201 |
Product Classification |
Acid, folic, radioimmunoassay - Product Code CGN
|
Product | 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 |
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. |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 333 Coney St East Walpole MA 02032-1516
|
For Additional Information Contact | SAME 508-668-5000 |
Manufacturer Reason for Recall | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | 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. |
Quantity in Commerce | 1,865 kits |
Distribution | Nationwide
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Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = CGN
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