Medical device manufacturer, Roche, has issued a field safety notice concerning cobas c pack CARB3. The affected catalogue number is 04874625190 and the affected lot numbers are 676413, 689905 and 692916.
On 30 April 2012, the manufacturer announced the Initial Cassette Volume Check (ICVC) has been activated on the reagent barcode labels of all Roche manufactured reagents which require manual filling in order to prevent erroneous results caused by incorrect filling of reagent. CARB3 (Cat: 04874625 190) is one of these reagents. However, the recent internal data showed that the ICVC is not performed on cobas c 502 for any lot so far.
Due to an in-house labeling software limitation, the ICVC "on" trigger are not correctly encoded in the REC files released to the market so far, and in consequence no ICVC was performed on cobas c 502 for tests requiring manual reagent handling.
The manufacturer has released the updated REC files which include correct ICVC "on" trigger for the affected reagent lots and will implement the ICVC "ON" setting in the corresponding REC file for all upcoming reagent lots.
The manufacturer advises users to update the cobas link which is connected to cobas 8000 with the c502 e-library update CD.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 20 March 2014