FDA Medical Device Recalls (openFDA)
Diagnostica Stago, Inc.: STA Liatest Free Protein S For in vitro diagnostic use. 2-8 degrees C Distributed in the USA by: Diagnostica Stago, Inc. 5 Century Drive Parsippany, NJ Phone 800-abc coag 1 - 6 x 5 ml Buffer 2 - 6 x 6 ml Latex
- Recall number
- Z-1072-2007
- Recalling firm
- Diagnostica Stago, Inc.
- Product
- STA Liatest Free Protein S For in vitro diagnostic use. 2-8 degrees C Distributed in the USA by: Diagnostica Stago, Inc. 5 Century Drive Parsippany, NJ Phone 800-abc coag 1 - 6 x 5 ml Buffer 2 - 6 x 6 ml Latex
- Status
- Terminated
- Initiated
- 2007-05-08
- Posted
- 2007-08-09
- Terminated
- 2010-10-13
- Reason
- Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit.
- Root cause
- Other
- Action
- Customers were sent a Product Recall Notification on May 8, 2007 by first class mail labeled " Recall notice, Open Immediately"
- Quantity
- 365 units
- Distribution
- Medical facilities nationwide
- Lot, serial or model codes
- Catalog number: 0516 Lot Numbers: 061312, Exp 5/31/07; 061991, Exp 8/31/07; 062633, Exp 10/31/07; 063281, Exp 12/31/07
- 510(k) numbers
- ["K912468"]
- PMA numbers
- not on file
- Product code
- GGP
- 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