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.
- Company
- Diasorin Inc.
- Recall Initiated
- March 16, 2015
- Posted
- April 20, 2015
- Terminated
- September 15, 2015
- Recall Number
- Z-1464-2015
- Quantity
- 451 kits
- Firm Location
- Stillwater, MN
Reason for Recall
Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.
Distribution
Worldwide Distribution - US in the state of CA and the countries of: CHINA, BELGIUM, ARGENTINA, and INDIA.
Lot / Code Info
131716, 131716A, 131716B, 131716C, 131716D, 131716E, 131717.
Root Cause
Under Investigation by firm
Action Taken
DiaSorin sent a Customer Notification Letter" to affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were asked to complete and return the confirmation form to the manufacturer. For questions contact DiaSorin Inc. Product Support at 1-800-328-1482.
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