Recall Z-1464-2015— Diasorin Inc.
Class II · Terminated
Class II FDA medical device recall by Diasorin Inc., initiated 2015-03-16, terminated 2015-09-15. FDA's recall record names no specific 510(k) clearance for this event. Product: DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy.. Reason: Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results..
- Recalling firm
- Diasorin Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-16
- Terminated
- 2015-09-15
- Firm location
- Stillwater, MN, United States
Product description
DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy.
Reason for recall
Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.