FDA Medical Device Recalls (openFDA)
Diagnostica Stago, Inc.: STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
- Recall number
- Z-3047-2026
- Recalling firm
- Diagnostica Stago, Inc.
- Product
- STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
- Status
- Open, Classified
- Initiated
- 2026-07-29
- Posted
- 2026-08-28
- Terminated
- not on file
- Reason
- A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
- Root cause
- Under Investigation by firm
- Action
- Diagnostica Stago issued an URGENT: MEDICAL DEVICE RECALL (REMOVAL) notice to its consignees on 7/29/2026 via email. The notice described the issue, risk assessment, and requested the following: "Actions Required To prevent potential workflow disruptions associated with the increased recalibration frequency, we request that you: " Immediately discontinue use of STA-Staclot Protein S, Lot 273074. " Dispose of any remaining inventory of the affected lot in accordance with your facility's procedures and local regulations. " Complete, sign, and return the enclosed Acknowledgement Form by email to confirm receipt and understanding of this notification. Stago will provide a credit for the destroyed kits you indicate on the Acknowledgement Form." For questions regarding this notice or require assistance, please contact Stago's 24/7 Hotline at 1-800-725-0607.
- Quantity
- 5220 units
- Distribution
- US Nationwide distribution in the states and territory of NJ, NY, NJ, VA, PA, FL, AL, GA, TN, OH, IL, MO, NE, TX, CO, UT, CA, PR.
- Lot, serial or model codes
- UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027
- 510(k) numbers
- ["K913424"]
- 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