Coagulation Factor VIII Deficient Plasma (OTXW). Factor… recallZ-1374-05 · Dade Behring , Inc. · initiated Jul 8, 2005
Terminated All recalls posted in August 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Dade Behring , Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
sample may exhibit falsely high results
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1374-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 8, 2005
- Posted by the FDA
- Aug 16, 2005
- Recalling firm
- Dade Behring , Inc.
- Quantity
- 3255 packs
- Product code
- GJT
- FDA submissions
- K924396
- 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 description
Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test
Code information (models, lots, serial numbers)
Lot numbers 503845A, 503846A, and 503847D
Other devices under the same FDA submission
2 devices cleared under K924396 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Coagulation Factor IX Deficient Plasma 10446414Siemens Healthcare Diagnostics Products GmbH · PLASMA, COAGULATION FACTOR DEFICIENT5 reports
- Coagulation Factor VIII Deficient Plasma 10446411Siemens Healthcare Diagnostics Products GmbH · PLASMA, COAGULATION FACTOR DEFICIENT3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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