FDA Medical Device Recalls (openFDA)
Dade Behring , Inc.: Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials
- Recall number
- Z-0773-04
- Recalling firm
- Dade Behring , Inc.
- Product
- Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials
- Status
- Terminated
- Initiated
- 2004-03-01
- Posted
- 2004-07-20
- Terminated
- 2004-08-19
- Reason
- cloudy appearance or precipitate
- Root cause
- Other
- Action
- 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.
- Quantity
- 77886 vials
- 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.
- Lot, serial or model codes
- Lot numbers 523785, 523785A, 523785B, and 523787
- 510(k) numbers
- ["K955450"]
- PMA numbers
- not on file
- Product code
- GFO
- 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