FDA Medical Device Recalls (openFDA)
Diagnostica Stago, Inc.: Staclot LA 20 (REF 00594) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).
- Recall number
- Z-0611-2019
- Recalling firm
- Diagnostica Stago, Inc.
- Product
- Staclot LA 20 (REF 00594) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).
- Status
- Terminated
- Initiated
- 2018-11-14
- Posted
- not on file
- Terminated
- 2020-06-08
- Reason
- There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
- Root cause
- Nonconforming Material/Component
- Action
- The firm, STAGO, sent a "Field Safety Notice" to its customers on 11/14/18. The notices describe the product, problem and actions to be taken. The customers were instructed to do the following: If you have any lots listed in the appendix in your laboratory, stop using and destroy the concerned kits; contact our sales administration team (1-800-222-2624 prompt #3) as soon as possible in order to obtain a replacement lot and complete the attached coupon acknowledging receipt of the letter. For additional information, please contact the STAGO hotline (1-800-725-0607) or email: Donald.kraft@us.stago.com or 1-973-631-1200 ext 4104.
- Quantity
- 22342 total
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Lot #s 251504, 251916, 252243, 252364, 252887, 253211
- 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