Advia 1200 chemistry systems (2015-05-08)

Starting date:

May 8, 2015

Posting date:

June 3, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-53631

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  Reason
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  Affected products

Recalled Products

1. Advia 1200 chemistry system - TDM Calibrations
2. Advia Chemistry System-TDAM Calibrators

Reason

Customer complaints indicate intermittent calibration failures due to max fit deviations when using digoxin reagents (SMN 10327549) with therapeutic drug monitoring (TDM) calibrator lot 300645. In most cases customers were able to recalibrate the assay after repeat calibrations. If digoxin calibration does not pass on the Advia chemistry system, patient samples cannot be run or reported. There are only two current lots of TDM calibrators and both were evaluated for max fit deviations. This confirmed failure when using TDM calibrator lot 300645. The new TDM calibrator lot 324889 did not have any failed calibrations due to max fit deviations. The TDM calibrator is used only for the digoxin assay.

Affected products