Recall Z-1519-2011 ยท GJS Test, Time, Prothrombin
Fisher Diagnostics, A Company of Fisher Scientific LLC
Pacific Hemostasis Thromboplastin-DS, catalog #100354, packaged in 4 mL lypholyzed vials, 10 bottles/carton. Vials are labeled, in part ***Fisher Diagnostics a division of Fisher Scientific Company, LLC Middletown, VA 22645-1905 USA*** Thromboplastin-DS is a Class 2 medical device intended for use in performing the one stage prothrombin time (PT) test and PT-based factor assays.
| Date | Oct 6, 2010 |
| Status | Terminated |
| Reason | An in vitro diagnostic reagent used in coagulation testing may cause inaccurate clotting times in quality control and patient plasma samples. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, ThermoFisher Scientific, sent two "Urgent Medical Device Removal" letters one via Federal Express on October 20, 2010 and certified mail for domestic customers on October 21, 2010. The letters described the product, problem and action to be taken by the customers. The customers were instructed to indicate the quantities of all affected product currently in stock at their facility; complete and return the attached Response Form/table to Fisher Diagnostics via fax to (540) 869-8129 or by mail to the attention of Technical Support; dispose of any remaining inventory of the affected lot |
| Quantity | 1190 kits |
| Distribution | Worldwide distribution: USA including states of: Alaska, Florida, Kentucky, Ohio, New Jersey, New York, and Texas; and countries including: Argentina, Dubai, Italy, Mexico, Philippines, Romania, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940082 | THROMBOSCREEN THROMBOPLASTIN-DS Pacific Hemostasis, Feb 14, 1995 |