Recall Z-0077-2019 ยท GJS Test, Time, Prothrombin
Instrumentation Laboratory Co.
Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family of analyzers. The product is intended to be used for the evaluation of the extrinsic
| Date | Aug 1, 2018 |
| Status | Terminated |
| Reason | There is a potential for increased imprecision, out of range quality controls and prolonged sample results. |
| Root cause | Material/Component Contamination |
| Action | On August 1, 2018, Instrumentation Laboratory issued Urgent Medical Device Removal and Field Safety notices to their customers. Customers were advised to take the following actions: - Run quality controls with each vial and a minimum of every 8 hours per labeled insert instructions to identify possible vials with the above performance issues until an alternative product lot of HemosIL ReadiPlasTin or an alternative PT reagent has been received and is ready for use. NOTE: ACL TOP Family and ACL TOP Family 50 Series analyzers can be configured to automatically perform QC at vial change. Ref |
| Quantity | 9751 kits |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122584 | HEMOSIL READIPLAS TIN Instrumentation Laboratory CO, Mar 24, 2013 |