OtherMLM
IMX TACROLIMUS II REAGENT PACK
Received Nov 8, 2007 · Event occurred Oct 25, 2007
Report 1415939-2007-00241 · MDR key 938884
Device
Generic name
Meia For The Measurement Of Tacrolimus
Manufacturer
Abbott LaboratoriesModel number
NACatalog number
3C10-20
Lot number
53637M100
Product problems
- Incorrect Or Inadequate Test Results
Patient
UNK YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER STATES, THAT IMPRECISION IS BEING SEEN WITH THE IMX TACROLIMUS II ASSAY. PATIENT #1 GENERATED RESULTS OF 9.6, 5.1, AND 17.1 NG/ML. CONTROLS HAVE BEEN WITHIN SPECIFICATION. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.