Z-1374-05

Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test

Name: Z-1374-05 Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test
Creator: Dade Behring , Inc.
Published: 2005-07-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2005-07-08 / Terminated

FDA source

Dade Behring , Inc. began a recall of Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test on 2005-07-08. The reason FDA records is "sample may exhibit falsely high results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1374-05
Status: Terminated
Initiated: 2005-07-08
Posted: 2005-08-16
Terminated: 2006-08-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test
Product code: GJT Plasma, Coagulation Factor Deficient
Reason for recall: sample may exhibit falsely high results
FDA root cause: Other
Action: On 7/13/05, the recalling firm issued letters to their customers informing them of the problem and the need to discontinue use and to discard any remaining product.
Quantity in commerce: 3255 packs
Distribution: The product was shipped to medical facilities and laboratories in AR, AZ, CA, FL, GA, ID, IL, IN, KS, KY, MA, MD, NC, ND, NV, NY, OH, OK, PA, TX, VA, WA, WI, and WV. The products were also shipped to Germany, Belgium, Switzerland, Sweden, Netherlands, Russia, Spain, France, Italy, Portugal, Australia, Chile, China, Saudi Arabi, Taiwan, and Uraguay.
Product codes and lots: Lot numbers 503845A, 503846A, and 503847D

Product code GJT

K924396Class IIClotting Factor-VIII-IX-XI-XII Deficient PlasmaBehring Diagnostics, Inc. / cleared 1993-05-21

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)