Dade Actin FS Activated PTT Reagent. Reagent and Control… recallZ-0304-06 · Dade Behring , Inc. · initiated Sep 23, 2005
Terminated All recalls posted in December 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
prolonged aPTT results
FDA root cause category: Other
What the company is doing
The recalling firm issued a letter dated 9/30/05 informing the customers of the problem and instructing them to discontinue use of the product.
Recall details
- Recall number
- Z-0304-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 23, 2005
- Posted by the FDA
- Dec 23, 2005
- Recalling firm
- Dade Behring , Inc.
- Quantity
- 4176 packs
- Product code
- GGW
- FDA submissions
- K811589
- Distribution
- The products were shipped to medical facilities and/or laboratories nationwide.
Product description
Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100
Code information (models, lots, serial numbers)
Lot number 527263 exp 2/3/06
Other devices under the same FDA submission
2 devices cleared under K811589 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dade® Actin® FS Activated PTT Reagent 10445710Siemens Healthcare Diagnostics Products GmbH · TEST, TIME, PARTIAL THROMBOPLASTIN7 reports
- Dade® Actin® FS Activated PTT Reagent 10445712Siemens Healthcare Diagnostics Products GmbH · TEST, TIME, PARTIAL THROMBOPLASTIN7 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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