Medical device manufacturer, BioMérieux, has issued a field safety notice concerning its VITEK 2 AST-P586 Test Kit 20 Cards (Lot number: 366386410; Expiration: 13 Jul 2017).
The manufacturer received customer reports regarding an issue related to Out-of-Range-Low (OORL) Ampicillin/Sulbactam QC results for Escherichia coli ATCC 35218, a Package Insert QC strain, in association with VITEK 2 AST-P586 test kit, lot 366386410. Internal investigation at the manufacturing site has confirmed the OORL Ampicillin/Sulbactam QC results. In addition, the investigation determined the Ampicillin/Sulbactam MIC results for the gram-positive organisms claimed by the VITEK 2 AST-P586 test kit are not affected (i.e. Staphylococcus spp., Enterococcus spp. and Streptococcus agalactiae).
According to the manufacturer, the issue is limited to the affected lot. There are no reports or evidence to suggest the issue exists for any other test kit lot. Evaluation of the identified issue indicates no potential for erroneous patient MIC results due to the OORL Ampicillin/Sulbactam QC result. However, Escherichia coli ATCC 35218 must be repeated to success, or an alternate method must be used to obtain Ampicillin/Sulbactam MIC results
The manufacturer advises users to dispose of the remaining affected lot in their stock. Product replacement is on-going
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 15 February 2017