Reported Mar 27, 2024 · Ongoing
DCA Systems HbA1c Reagent Kit
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- DCA Systems HbA1c Reagent Kit
- Lot codes and dates
- Siemens Material Number10311134
- UDI/DI
00630414532806Lot#: 96400930645103064810306491030654103
- Expanded Lots (02/28/2024)
063709306410930642093064710306531030655103
- Amount recalled
- 74,211 Kits (Expanded 2/28/24: additional 72,892 kits)
Where it was sold
- Nationwide
Why it was recalled
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%.
This product could cause temporary or reversible health problems — stop using it.
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