Siemens Healthcare Diagnostics, Inc: ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.

Is my product affected?

ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.

• UPC 00630414124803

Check against the official notice below — it lists the full affected range.

What happened

Siemens Healthcare Diagnostics is recalling 1,870 ADVIA Centaur CKMB Calibrator kits used to calibrate CKMB assays on ADVIA Centaur systems. The recall affects four lot numbers (57834A64, 57835A64, 72519A64, and 98115A64), all expiring December 11, 2018, distributed nationwide in the United States.

A potential bias was identified in these kits when compared to internal standards. The source document does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

A potential bias was identified with certain kits compared to the internal standards.

Details from the source

Reason for recall: A potential bias was identified with certain kits compared to the internal standards. Distribution: US Nationwide Distribution Quantity: 1870 kits Lot/code info: SMN 10311570 Lot # Expiry UDI # 57834A64 2018-Dec-11 (01)00630414124803(10)57834A64(17)20181211 57835A64 2018-Dec-11 (01)00630414124803(10)57835A64(17)20181211 72519A64 2018-Dec-11 (01)00630414124803(10)72519A64(17)20181211 98115A64 2018-Dec-11 (01)00630414124803(10)98115A64(17)20181211

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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