Recall Z-0832-2015 ยท GJS Test, Time, Prothrombin
Instrumentation Laboratory Co.
HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral An
| Date | Dec 19, 2014 (initiated Nov 21, 2014) |
| Status | Terminated |
| Reason | Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June 2014) exhibit a yellow/brownish color after reconstitution (yellow color or darker) instead of the typical white to off-white color. Vials exhibiting this yellow/brownish color were observed to cause prolonged prothrombin (PT) clotting times. |
| Root cause | Process design |
| Action | The firm, Instrumentation Laboratory, sent an "URGENT MEDICAL DEVICE CORRECTION" letter (dated 11/21/2014) to US and Canadian customers via USPS on 11/21/2014 for all in-date lots of HemosiL PT-Fibrinogen HS PLUS, Part No. 0008469810, manufactured prior to June 2014. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: if they observe any yellow/brownish color after reconstitution, they are not to use the affected vial; discard the vial and reconstitute another vial; only use a vial if the reconstituted color is the typical whit |
| Quantity | USA: 4088 kits; Foreign: 97,925 kits |
| Distribution | Worldwide Distribution: US (nationwide) including Puerto Rico; and countries of: ALBANIA, ALGERIA, ANDORRA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BELARUS, BRAZIL, BRUNEI, BULGARIA, CHILE, CHINA, COLUMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, FRANCE, GABON, GEO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060931 | HEMOSIL PT-FIBRINOGEN HS PLUS Instrumentation Laboratory CO, May 2, 2006 |