FDA Medical Device Recalls (openFDA)
Diasorin Inc.: DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitative determination of trypsin-like immunoreactiviy (TLI) in human serum or plasma samples)
- Recall number
- Z-0748-2007
- Recalling firm
- Diasorin Inc.
- Product
- DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitative determination of trypsin-like immunoreactiviy (TLI) in human serum or plasma samples)
- Status
- Terminated
- Initiated
- 2007-02-15
- Posted
- 2007-04-14
- Terminated
- 2007-07-15
- Reason
- Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay)
- Root cause
- Other
- Action
- The consignees & distributors were notified by letter on 2/15/07 . The Distributors are instructed to forward the notification to the customers who have received the affected products. A response form will be requested from the customers.
- Quantity
- 100 kits
- Distribution
- Worldwide Distribution --- USA including states of UT, CO, IN, NC, CA, FL and countries of Canada, Spain, Germany, Belgium & Italy.
- Lot, serial or model codes
- Part # P2573, Lot 118532
- 510(k) numbers
- ["K791202"]
- PMA numbers
- not on file
- Product code
- JNO
- 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