MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination
FDA device recall Z-2867-2017 · posted 2017-06-27 · Terminated
Recall details
- Recalling firm
- Sentinel CH SPA
- Reason for recall
- Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.
- Action taken
- Sentinel Diagnostics notified the US Distributor on 5/22/17 to notify US customers by letter. Actions to be Taken 1. Discontinue the use of the impacted lots immediately and destroy any remaining inventory of impacted lots according to your laboratory procedures. 2. If you have an alternate reagent lot available in inventory, switch to this alternate lot, or use a new lot provided. 3. Please review the content of this communication with your Medical Director and retain this letter for any future reference. Questions regarding this information, U.S. Customers should contact Customer Service at 1-877-4 ABBOTT. Customers to complete Field Safety Notice Receipt.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JFY
- Quantity affected
- 2356 kits Worldwide; US 206 kits
- Distribution
- Nationwide Distribution
- Date initiated
- 2017-05-22
- Date posted
- 2017-06-27
- Date terminated
- 2018-09-04
- Location
- Milan, Italy
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MULTIGENT CREATININE (ENZYMATIC) ASSAY (K073634) | SENTINEL CH. SpA | 2008-06-19 |