BC Thrombin Reagent . Thrombin Time Test recallZ-0007-05 · Dade Behring , Inc. · initiated Jul 21, 2004
Terminated All recalls posted in October 2004
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
The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin
FDA root cause category: Other
What the company is doing
The recalling firm issued a recall letter dated 7/21/04 to their accounts informing them of the problem and the need to discard the product.
Recall details
- Recall number
- Z-0007-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 21, 2004
- Posted by the FDA
- Oct 5, 2004
- Recalling firm
- Dade Behring , Inc.
- Quantity
- 3942 kits
- Product code
- GJA
- FDA submissions
- K970645
- Distribution
- The products were shipped to medical facilities in CT, FL, IA, IL, NJ, PA, and WI. The products were also shipped to Austria, Bosnia, Croatia, Hungry, Germany, Poland, Spain, RussiaFrance, Italy, Australia, Brazil, Canada, Saudi Arabia, El Salvador, and Turkey.
Product description
BC Thrombin Reagent . Thrombin Time Test
Code information (models, lots, serial numbers)
Lot 540624, Lot 540625, and Lot 540626
Other devices under the same FDA submission
1 device cleared under K970645 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BC Thrombin Reagent 10446636Siemens Healthcare Diagnostics Products GmbH · TEST, THROMBIN TIME9 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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