Recall Z-0895-2018 ยท GJS Test, Time, Prothrombin
Instrumentation Laboratory Co.
Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
| Date | Mar 3, 2018 (initiated Aug 2, 2017) |
| Status | Terminated |
| Reason | Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results. |
| Root cause | Under Investigation by firm |
| Action | On August 2, 2017, Instrumentation Laboratory sent an Urgent Medical Device Removal letters dated August 2, 2017 to their customers. On October 5, 2017 Instrumentation Laboratory expanded their recall adding 3 additional lots to a second Urgent Medical Device Removal letter. On February 26, 2018, Instrumentation Laboratory expanded their recall a 3rd time to include 1 additional lot to a third Urgent Medical Device Removal letter. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete a Mandatory Tracking Response form. For quest |
| Quantity | 14,894 kits |
| Distribution | Worldwide 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 |