DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitative determination of trypsin-lik
FDA device recall Z-0748-2007 · posted 2007-04-14 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay)
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JNO
- Quantity affected
- 100 kits
- Distribution
- Worldwide Distribution --- USA including states of UT, CO, IN, NC, CA, FL and countries of Canada, Spain, Germany, Belgium & Italy.
- Date initiated
- 2007-02-15
- Date posted
- 2007-04-14
- Date terminated
- 2007-07-15
- Location
- Stillwater, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RIA KIT FOR TRYPSIN (K791202) | Cis Radiopharmaceuticals, Inc. | 1979-11-05 |