FDA Medical Device Recalls (openFDA)
Dade Behring , Inc.: Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test
- Recall number
- Z-1374-05
- Recalling firm
- Dade Behring , Inc.
- Product
- Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test
- Status
- Terminated
- Initiated
- 2005-07-08
- Posted
- 2005-08-16
- Terminated
- 2006-08-10
- Reason
- sample may exhibit falsely high results
- 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
- 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.
- Lot, serial or model codes
- Lot numbers 503845A, 503846A, and 503847D
- 510(k) numbers
- K924396
- PMA numbers
- not on file
- Product code
- GJT
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28