FDA Medical Device Recalls (openFDA)
Diagnostica Stago, Inc.: Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay.
- Recall number
- Z-1441-06
- Recalling firm
- Diagnostica Stago, Inc.
- Product
- Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay.
- Status
- Terminated
- Initiated
- 2006-07-18
- Posted
- 2006-08-26
- Terminated
- 2006-11-06
- Reason
- Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants.
- Root cause
- Other
- Action
- Recall notification letters were sent out via first class mail on July 18, 2006.
- Quantity
- 4,365 kits
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot 050947D --exp. April 2007; Lot 051527A -- exp. June 2007; Lot 051527B -- exp. June 2007; Lot 051527C -- exp. June 2007; Lot 051527D -- exp. June 2007.
- 510(k) numbers
- ["K923731"]
- PMA numbers
- not on file
- Product code
- GFO
- Firm FEI
- 2245451
- Firm city
- Parsippany
- Firm state
- NJ
- 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