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.
FDA Recall Z-1519-2011 · Posted None
Recalling FirmFisher Diagnostics, A Company of Fisher Scientific LLC
Recall StatusTerminated
Product CodeGJS
Date Initiated2010-10-06
Date Terminated2011-11-02
Product Quantity1190 kits
Reason for Recall
An in vitro diagnostic reagent used in coagulation testing may cause inaccurate clotting times in quality control and patient plasma samples.
Firm 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 numbers; provide a copy of this letter to their customers, and file this letter for future reference.
If you have any questions regarding this notification, please contact our Technical Support staff at 800-528-0494, Option 2, or email [email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.