Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0873-05

Nichols Advantage Sample hGH Diluent Set (Catalog No. 62-7756)

Nichols Institute Diagnostics / initiated 2005-05-02 / Terminated

Nichols Institute Diagnostics began a recall of Nichols Advantage Sample hGH Diluent Set (Catalog No. 62-7756) on . The reason FDA records is "Under recovery of diluted samples by as much as 20%". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0873-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Nichols Institute Diagnostics
Product
Nichols Advantage Sample hGH Diluent Set (Catalog No. 62-7756)
Product code
CFL Radioimmunoassay, Human Growth Hormone
Reason for recall
Under recovery of diluted samples by as much as 20%.
FDA root cause
Other
Action
Recall letter was sent 5/2/2005 which requests return of the product, a response card was included.
Quantity in commerce
undetermined
Distribution
Nationwide and to Germany, Sweden, Italy, japan, Spain
Product codes and lots
All codes