Z-1519-2011

Pacific Hemostasis Thromboplastin-DS, catalog #100354, packaged in 4 mL lypholyzed vials, 10 bottles/carton...

Name: Z-1519-2011 Pacific Hemostasis Thromboplastin-DS, catalog #100354, packaged in 4 mL lypholyzed vials, 10 bottles/carton...
Creator: Fisher Diagnostics, A Company of Fisher Scientific LLC
Published: 2010-10-06
License: https://open.fda.gov/license/

Fisher Diagnostics / initiated 2010-10-06 / Terminated / root cause: manufacturing process

FDA source

Fisher Diagnostics, A Company of Fisher Scientific LLC began a recall of Pacific Hemostasis Thromboplastin-DS, catalog #100354, packaged in 4 mL lypholyzed vials, 10 bottles/carton. Vials are labeled, in part ***Fisher Diagnostics a... on 2010-10-06. The reason FDA records is "An in vitro diagnostic reagent used in coagulation testing may cause inaccurate clotting times in quality control and patient plasma samples". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1519-2011
Status: Terminated
Initiated: 2010-10-06
Posted: 2015-06-26
Terminated: 2011-11-02
Recalling firm: Fisher Diagnostics
Product: 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.
Product code: GJS Test, Time, Prothrombin
Reason for recall: An in vitro diagnostic reagent used in coagulation testing may cause inaccurate clotting times in quality control and patient plasma samples.
Root cause tag: manufacturing process
FDA 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 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].
Quantity in commerce: 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.
Product codes and lots: V40526, exp 4/2013 V40826, exp 4/2013

Product code GJS

K940082Class IIThromboscreen Thromboplastin-DsPacific Hemostasis / cleared 1995-02-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)