Recall Z-2867-2017 ยท JFY Enzymatic Method, Creatinine
Sentinel CH SPA
MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provide
| Date | Jun 27, 2017 (initiated May 22, 2017) |
| Status | Terminated |
| Reason | Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration. |
| Root cause | Nonconforming Material/Component |
| Action | 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 Servic |
| Quantity | 2356 kits Worldwide; US 206 kits |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073634 | MULTIGENT CREATININE (ENZYMATIC) ASSAY SENTINEL CH. SpA, Jun 19, 2008 |