Recall Z-3047-2026 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
Diagnostica Stago, Inc.
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
| Date | Aug 28, 2026 (initiated Jul 29, 2026) |
| Status | Open, Classified |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K913424 | STACLOT(R) PROTEIN S TEST KIT American Bioproducts Co., Oct 8, 1991 |