DCA Systems HbA1c Reagent Kit

FDA device recall Z-1304-2024 · posted 2024-03-19 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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%.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LCP

Quantity affected

74,211 Kits (Expanded 2/28/24: additional 72,892 kits)

Distribution

Worldwide distribution - US Nationwide and the country of Taiwan.

Date initiated

2024-02-07

Date posted

2024-03-19

Location

Tarrytown, NY

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