Recall Z-3280-2018

Reason for recall

Potential for positively biased results

FDA-determined cause: Nonconforming Material/Component

Action taken

On 05 May 2018, Customer letter (Ref. CL2018-123) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all VITROS customers, who have a analyzer capable of running VITROS Na+ slides, to inform them of the issue and to request that they immediately discontinue use of this VITROS Na+ Slides, GENs 8 and 13. Continued use of VITROS Na+ Slides, GENs14,16,17& 18 is acceptable provided the conditions detailed in the communication are met. Foreign affiliates were initially informed by email on 05 May 2018 of the issue and instructed to notify their consignees of the affected product with this issue and the requirement to immediately discontinue use of the VITROS Na+ slides GENs 8, 13, 14, 16, 17 and 18. Due to the amount of time required to ship replacement product to some worldwide locations, a revised communication to the foreign affiliates occurred on 08 June 2018. Due to the health risk associated with potentially leaving the laboratory without a Na+ method, the revised letter instructs customers that they may continue to use GENs 14, 16, 17 and 18 until replacement product is received.