Medical device manufacturer, Siemens Healthcare Diagnostics, has issued a medical device safety alert concerning its ADVIA Chemistry Systems A1c_3 calibrator [Catalogue no.: 10491408 & Lot no.: 3HD044; 3LD068].
The manufacturer is conducting a recall of the ADVIA Chemistry Systems A1c_3 calibrator lots 3HD044 and 3LD068. The manufacturer has confirmed that the ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (Hb)A1c samples when using A1c_3 calibrator lots 3HD044 and 3LD068. Depending on quality control limits, this issue may not have been detected. NOTE: The percent bias range is a percentage of the HbA1c result. It is NOT absolute HbA1c units.
According to the manufacturer, a percent bias of up to +11% may be considered clinically significant at clinically relevant HbA1c ranges between ~5.5% and 8.0%, and may result in the modification of the therapy for hyperglycemia. The modification of hyperglycemic therapy can increase the risk of occurrence of hypoglycemia, which may be observed through personal glucose monitoring and/or patient symptoms.
Affected users are advised to discontinue use of and discard the affected products. The manufacturer is not recommending a general look back for the laboratory for previously generated results when using these calibrator lots. The manufacturer is also providing a physician letter with retesting guidance for physicians.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 Aug 2014