Diagnostica Stago STA Staclot Protein S reagent recalled for QC drift
Diagnostica Stago identified a positive drift in quality control (QC) values in one lot of STA Staclot Protein S reagent within the product's stated 4-hour stability period. This drift could affect the accuracy of test results performed during that window. The issue affects reagent Lot 273074 distributed nationwide.
From the FDA notice · Read the official notice ↗ · All Diagnostica Stago recalls
What to do
- Check your facility's inventory for STA Staclot Protein S Lot 273074 (Exp 3/31/2027).
- Contact Diagnostica Stago or your supplier for instructions on return or replacement.
- Review any patient results generated with this lot and follow your laboratory's quality protocol.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
- Sold in
- Nationwide
- Made for
- All ages
Details
- Units affected
- 5220 units
- Illnesses reported
- None reported
- Manufactured in
- 5 Century Dr, N/A, Parsippany, NJ, United States
- Classification
- Class II
- Recall number
- Z-3047-2026
In the FDA's words
- Description
- STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027 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. Affected quantity: 5220 units
- Hazard
- A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified