FDA Medical Device Recalls (openFDA)
Sekisui Diagnostics Llc: Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.
- Recall number
- Z-2431-2012
- Recalling firm
- Sekisui Diagnostics Llc
- Product
- Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.
- Status
- Terminated
- Initiated
- 2012-08-28
- Posted
- 2012-09-20
- Terminated
- 2016-07-25
- Reason
- SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions.
- Root cause
- Process control
- Action
- The firm, Sekisui Diagnostics, LLC, sent an "URGENT PRODUCTS RECALL NOTICE" dated August 28, 2012 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to immediately stop using the product; to discard any remaining inventory and complete and return the Customer Acknowledgement Form by September 4, 2012 documenting the # of kits destroyed via FAX to Quality Assurance at 203-602-5553. The customers were also instructed to return the form even if they do not have the affected product currently in inventory. Sekisui will replace kits. If you have any questions contact, Customer Service Department at 800-637-3375, ext 10, 12, or 31, or email to recall coordinator at MKHAN@AMDIAG.COM.
- Quantity
- 699 kits
- Distribution
- Nationwide distribution: USA including states of: FL, IN, IL, and WA.
- Lot, serial or model codes
- Lot Numbers: 120425 and 120601
- 510(k) numbers
- ["K063323"]
- PMA numbers
- not on file
- Product code
- GGP
- Firm FEI
- 1220602
- Firm city
- Stamford
- Firm state
- CT
- 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