Recall Z-1464-2015
Diasorin Inc. · initiated March 16, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 131716, 131716A, 131716B, 131716C, 131716D, 131716E, 131717.
Reason for recall
Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.
FDA-determined 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.
Details
- Recall number
- Z-1464-2015
- Initiated
- March 16, 2015
- Posted by FDA
- April 20, 2015
- Terminated
- September 15, 2015
- Product code
- MLM – Enzyme Immunoassay, Tracrolimus
- Quantity
- 451 kits
- Distribution
- Worldwide Distribution - US in the state of CA and the countries of: CHINA, BELGIUM, ARGENTINA, and INDIA.
- Recalling firm
- Diasorin Inc., Stillwater, MN