Z-1150-2023Class II

Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in...

Name: Z-1150-2023 Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2023-01-09
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-01-09 / Open, Classified / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material... on 2023-01-09. FDA classified it as Class II and gives the reason as "Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1150-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-01-09
Posted: 2023-02-21
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573
Product code: CGN Acid, Folic, Radioimmunoassay
Reason for recall: Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Root cause tag: manufacturing process
FDA root cause: 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: 9,272 kits
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 codes and lots: UDI: (01)00630414598970(10)15307337(17)20230320; (01)00630414598970(10)27948339(17)20230529; (01)00630414598970(10)41142343(17)20230630; (01)00630414598970(10)62968345(17)20230726. Lot Numbers: 15307337, 27948339, 41142343, 62968345 and higher. All current and future lots of the ADVIA Centaur Folate assay until the Instructions for Use are updated

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1150-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1149-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-01	2023-02-21
Z-1150-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-01	2023-02-21
Z-1151-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-01	2023-02-21
Z-1152-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-01	2023-02-21
Z-1153-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-01	2023-02-21
Z-1154-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-01	2023-02-21

Product code CGN

K172201Class IIAtellica IM Folate AssaySiemens Healthcare Diagnostics, Inc. / cleared 2018-04-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)