Z-1304-2024Class II

DCA Systems HbA1c Reagent Kit

Name: Z-1304-2024 DCA Systems HbA1c Reagent Kit
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2024-02-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-02-07 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of DCA Systems HbA1c Reagent Kit on 2024-02-07. FDA classified it as Class II and gives the reason as "The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that erroneous test results could be reported...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1304-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-07
Posted: 2024-03-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: DCA Systems HbA1c Reagent Kit
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that erroneous test results could be reported and potentially lead to incorrect patient management of glucose control. A positive bias may be observed with eleven HbA1c affected lots. Positive bias was observed when the performance of these five HbA1c lots was compared to NGSP pooled patient target-value assigned samples and the maximum bias observed was 19%.
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Correction notification letter was sent to customers on 02/07/2024. Actions to be Taken by the Customer: Discontinue use of the reagent lots listed in Table 1. We are offering you the option to formally request a complimentary replacement product for discarded reagent kits through your local Siemens representative or authorized distributor by calling 877-885-4873. Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. If the lot number you are using is not listed in the table, you may continue using it. If you are a distributor, please ensure your customers receive this UMDC letter. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. 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. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Quantity in commerce: 74,211 Kits (Expanded 2/28/24: additional 72,892 kits)
Distribution: Worldwide distribution - US Nationwide and the country of Taiwan.
Product codes and lots: Siemens Material Number: 10311134; UDI/DI: 00630414532806; Lot#: 9640093, 0645103, 0648103, 0649103, 0654103 . Expanded Lots (02/28/2024): 0637093, 0641093, 0642093, 0647103, 0653103, 0655103;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1304-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1304-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-19

Product code LCP

K951361Class IIDca 2000 System for Hemoglobin A1cHeraeus Kulzer, Inc. / cleared 1995-05-05

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)