Device Recall Vital Diagnostics Envoy Calcium Reagent For InVitro Diagnostic Use 의 리콜

Recall

66202

Class 2

Z-0732-2014

2013-08-29

2014-01-14

Terminated

United States

2015-08-26

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121742

High positive calcium bias on plasma sample versus results on serum.

Vital Diagnostics issued a Recall Notice dated August 29, 2013, to all affected customers via certified mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use plasma for the determination of total calcium when using the affected product. The use of serum is acceptable, thus the product can still be used to determine total calcium with this sample type. Vital Diagnostics released a corection to the package insert for the Envoy Calcium Reagent. Customers with the affected product in their laboratory, were instructed to discard the insert packed with the product and replace it with the insert enclosed with this bulletin. If product was transferred to another location, the bulletin should be forwarded to that location. The package insert was revised indicating to only use Serum samples when running Calcium. Vital Diagnostics issued a revised (expanded) notice dated September 19, 2013, to include the Consult Diagnostics¿ Eon Calcium Reagent (PN: 1429) requesting users to discontinue using the single vial Eon Calcium kit (PN: 1429). Customers with questions were instructed to call Vital Diagnostics Technical Support at 1-855-354-8324.. For questions regarding this recall call 401-642-8400.