ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.
Check against the official notice below — it lists the full affected range.
Abbott Laboratories is recalling ARCHITECT STAT Myoglobin Calibrators lot RES 2K43-01 because the calibrator lot failed to meet acceptance criteria during stability testing. When this lot is used to calibrate the ARCHITECT iSystem with STAT protocol capability, quality control results may exceed the ranges specified in the product's instructions for use. A total of 402 kits with this lot number were distributed worldwide, including throughout the United States and in numerous countries across Europe, the Middle East, Africa, and other regions.
The recall affects calibrators with UDI (01)00380740003272(17)220531(10)166000. The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).
Reason for recall: This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU). Distribution: Worldwide Distribution: US (nationwide) and OUS (foreign) including countries of: AUSTRIA, BELGIUM, BOSNIA AND HERZEGOVI, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, GREECE, IRAQ, ITALY, KAZAKHSTAN, LITHUANIA, LUXEMBOURG, MACEDONIA, MOROCCO, PANAMA, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SOUTH AFRICA, SWEDEN, SWITZERLAND, and TURKEY Quantity: 402 kits Lot/code info: UDI: (01)00380740003272(17)220531(10)166000
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.