Pathromtin SL. Partial Thromboplastin Time Tests. The… recallZ-0773-04 · Dade Behring , Inc. · initiated Mar 1, 2004
Terminated All recalls posted in July 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
cloudy appearance or precipitate
FDA root cause category: Other
What the company is doing
The recalling firm issued recall letters dated 3/4/04 to their direct accounts informing them of the problem and what to do if a vial is found to be cloudy.
Recall details
- Recall number
- Z-0773-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 1, 2004
- Posted by the FDA
- Jul 20, 2004
- Recalling firm
- Dade Behring , Inc.
- Quantity
- 77886 vials
- Product code
- GFO
- FDA submissions
- K955450
- Distribution
- The products were shipped to one diagnostic facility in PA. The products were also shipped to Germany, Poland, Spain, France, Italy, Portugal, Mexico, Thailand, and Uruguay.
Product description
Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials
Code information (models, lots, serial numbers)
Lot numbers 523785, 523785A, 523785B, and 523787
Other devices under the same FDA submission
2 devices cleared under K955450 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Pathromtin® SL 10446066Siemens Healthcare Diagnostics Products GmbH · ACTIVATED PARTIAL THROMBOPLASTIN11 reports
- Pathromtin® SL 10446067Siemens Healthcare Diagnostics Products GmbH · ACTIVATED PARTIAL THROMBOPLASTIN3 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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