FDA Medical Device Recalls (openFDA)
Diasorin Inc.: 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.
- Recall number
- Z-1464-2015
- Recalling firm
- Diasorin Inc.
- 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.
- Status
- Terminated
- Initiated
- 2015-03-16
- Posted
- 2015-04-20
- Terminated
- 2015-09-15
- Reason
- Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 451 kits
- Distribution
- Worldwide Distribution - US in the state of CA and the countries of: CHINA, BELGIUM, ARGENTINA, and INDIA.
- Lot, serial or model codes
- 131716, 131716A, 131716B, 131716C, 131716D, 131716E, 131717.
- 510(k) numbers
- not on file
- PMA numbers
- ["P970025"]
- Product code
- MLM
- Firm FEI
- 2182595
- Firm city
- Stillwater
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28