Summary
The FDA issued a Class II for DCA Systems HbA1c Reagent Kit by Siemens Healthcare Diagnostics, Inc.. Reason: 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 .
Details
Source
Device Recall
External ID
Z-1304-2024
Action Date
2024-03-27
Status
Ongoing
Category
device
Product Description
DCA Systems HbA1c Reagent Kit
Lot/Code Info: Siemens Material Number: 10311134; UDI/DI: 00630414532806; Lot#: 9640093, 0645103, 0648103, 0649103, 0654103 . Expanded Lots (02/28/2024): 0637093, 0641093, 0642093, 0647103, 0653103, 0655103;
Quantity Affected: 74,211 Kits (Expanded 2/28/24: additional 72,892 kits)
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%.
Distribution
Worldwide distribution - US Nationwide and the country of Taiwan.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-07
Company
Tarrytown, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Healthcare Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Healthcare Diagnostics, Inc. have FDA actions?
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1304-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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