Diagnostica Stago, Inc.: Test, Qualitative And Quantitative Factor Deficiency
- Recalling firm
- Diagnostica Stago, Inc.
- Product
- STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
- Reason
- A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-29
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/95fdad92-1e9d-45a1-9f41-e5f3d2ea7022