Important Safety Alerts

Medical device manufacturer, Roche Diagnostics International Ltd, has issued a medical device safety alert concerning its Elecsys Vitamin D total II [Product Description (Catalog Number): A) Elecsys Vitamin D total II - 100 tests (07464215190); B) Elecsys Vitamin D total II - 300 tests (07028148190)].

The manufacturer has received a number of reports of performance issues (i.e. non-reproducible, false high results) during the implementation of the Elecsys Vitamin D total II assay on MODULAR ANALYTICS E 170, cobas e 601 and cobas e 602 systems.

The observations were made in duplicate measurements during assay validation of Elecsys Vitamin D total II or in method comparisons with Elecsys Vitamin D total, where the falsely-elevated discrepant value did not fit the expected result. When repeated, the elevated results were not confirmed in reruns. The issue manifests as follows:

• The first result is elevated, either above the upper end of the measuring range (>100 ng/ml or >250 nmol/mL) or within the measuring range; and repeats are significantly lower.

According to the manufacturer, the issues have been seen on MODULAR ANALYTICS E 170, cobas e 601 and cobas e 602 systems with an occurrence of between 1/100,000 and 1/1,000,000 tests sold. Rare cases have been reported on cobas e 411 and cobas e 801.

The manufacturer temporarily blocked the distribution of the affected product assay on MODULAR ANALYTICS E 170, cobas e 601 and cobas e 602 systems. It is carrying out further investigations to understand the underlying root cause and conditions under which this issue arises

The affected users are advised to do the following actions prior to measurements with Elecsys Vitamin D total II on all analyzers:

• Do a thorough inspection of your pre-analytical handling for a correct assay performance of Elecsys Vitamin D total II and to comply to the individual specifications of the primary tube manufacturers for all tubes in use (in particular the centrifugation conditions are important and the elimination of foam).
• If the issue persists, switch from plasma to serum.
• If they still encounter the issue on plasma or serum, do a re-centrifugation in a secondary tube for 10 min at 2000 x g prior to measurement with Elecsys Vitamin D total II.

If the above suggestions did not improve the issue, the users should consider switching to Vitamin D total (06506780160) or Elecsys Vitamin D total (05894913190) and contact the manufacturer.

According to the local supplier, the affected product is distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 25 April 2018