Z-0102-2021Class II

Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of...

Name: Z-0102-2021 Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2020-09-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-09-22 / Open, Classified / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma... on 2020-09-22. FDA classified it as Class II and gives the reason as "Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0102-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-09-22
Posted: 2020-10-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 11097637
Product code: JIT Calibrator, Secondary
Reason for recall: Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens Urgent Medical Device Recall (ACHC20-18.A.US.CHC) distributed to customers on 9/22/20, in the United States and an Urgent Field Safety Notice (ACHC20-18.A.OUS.CHC) was distributed to customers outside the United States who have received ADVIA Chemistry Fructosamine in-date reagent lots. For Atellica, an Urgent Medical Device Recall (ACHC20-18.A.US) was distributed to l customers in the United States and an Urgent Field Safety Notice (ACHC20-1.OUS) was distributed to all customers outside the United States who have received Atellica CH in date reagent lots. These letters instruct the customers to: Perform the following actions on the ADVIA Chemistry System 1. Enter the Real-time correction factor in the Analytical Parameters (Chemistry) window. 2. Once the Real-time correction factor has been configured, update QC ranges as described above in the FRUC QC Definition following your laboratory procedures. 3. Update the reference range following your laboratory procedures. 4. Perform a FRUC calibration and process QC. 5. Perform a system back-up. Complete and return the Field Correction Effectiveness Check attached to this letter within 30 days. " Review this letter with your Medical Director. " If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative
Quantity in commerce: US: 28; OUS: 255 units
Distribution: CA, DE, MD, NC, NJ, NY, PA Foreign: Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Brazil¿¿¿¿ Canada¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Netherlands¿¿¿¿ P.R.¿China¿¿¿¿¿ Paraguay¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿ United¿Kingdom¿ Vietnam¿¿¿¿¿¿¿¿
Product codes and lots: All lots UDI: (01)00630414595580(10)201115(17)20210201 (01)00630414595580(10)201207(17)20210601

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0102-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0101-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-21	2020-10-13
Z-0102-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-21	2020-10-13

Product code JIT

K131307Class IIAdvia Chemistry Fructosamine Assay, Advia Chemistry Fructosamine CalibratorSiemens Healthcare Diagnostics, Inc. / cleared 2014-01-24

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)