Important Safety Alerts

Roche Diagnostics has issued a medical device safety alert concerning PROBE SAMPLE (GMMI 04547241001), PROBE SAMPLE S (GMMI 05899427001) and SAMPLE PROBE (GMMI 04945794001), manufactured by Hitachi High Technologies Corporation.

The following Roche analysers have been delivered with potentially affected sample probes: cobas c 501 module (cat. no. 04745914001); cobas c 502 module (cat. no. 05964067001); cobas c 702 module (cat. no. 06473245001); cobas 8000 ISE module 900 (cat. no. 05641497001); cobas 8000 ISE module 1800 (cat. no. 05964075001).

In very rare cases, a disturbance of the sample liquid level detection (LLD) may occur due to a fretting corrosion on the sample probe connector due to a production change for the connector. In those very rare cases where the disturbance of the sample liquid level detection (LLD) occurs, the affected sample probe may dip into the sample material deeper than intended, accordingly the affected sample probe may be not washed adequately (this may lead to carryover, medical risk cannot be excluded).

The manufacturer, Hitachi High Technologies Corporation, has clearly identified the root cause and since the beginning of 2017, the affected sample probe connector type has been changed in production to a new connector type. With that new connector type the sample LLD is ensured to fully function as specified.

Affected users are instructed to take the following actions:-

• Enable the "Clot Detection" and "Clot Detection for Calib./Control" settings in "Utility-System-Alarm Settings" "How to proceed whenever the system alarm "Sample Short" or "Abnormal Aspiration" is issued" relevant to the analyzer/module type used in their laboratory).
• Until the sample probe exchange takes place, whenever the analyzer issues the system alarm "Sample Short" or "Abnormal Aspiration" for a sample with sufficient sample volume, affected users follow the instructions in the attachment(s) "How to proceed whenever the system alarm "Sample Short" or "Abnormal Aspiration" is issued" relevant to the analyzer/module type used in their laboratory.
• If carryover cannot be excluded, affected samples should be handled according to the local regulations including the decision whether previously generated results should be reviewed.

According to the local supplier (Roche Diagnostics), the affected products are distributed in Hong Kong.

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

Posted on 10 March 2017