FDA Medical Device Recalls (openFDA)
Diagnostica Stago, Inc.: PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., Five Century Drive, Parsippany, NJ 07054.
- Recall number
- Z-1419-05
- Recalling firm
- Diagnostica Stago, Inc.
- Product
- PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., Five Century Drive, Parsippany, NJ 07054.
- Status
- Terminated
- Initiated
- 2005-04-13
- Posted
- 2005-08-30
- Terminated
- 2006-10-03
- Reason
- Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent.
- Root cause
- Other
- Action
- On 4/13/2005, recall notification letters were sent to all customers and instructed them to stop using the kits and to dispose of the kits according to local regulations.
- Quantity
- 740 kits
- Distribution
- The firm distributed this product to 32 clinics/laboratories/hospitals nationwide.
- Lot, serial or model codes
- Cat. No. 00599 Lot Number 041755 exp. 06/06.
- 510(k) numbers
- ["K921684"]
- PMA numbers
- not on file
- Product code
- GGW
- 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