Diagnostica Stago Recalls STA Staclot Protein S Reagent Due to QC Drift
Diagnostica Stago is recalling 5,220 units of STA Staclot Protein S reagent because quality control values drifted within the stated stability period.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a quality control drift affecting test reliability, which fits the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Diagnostica Stago, Inc. is recalling 5,220 units of STA Staclot Protein S reagent, Model/Catalog Number 00746, Lot number 273074. The product is a qualitative and quantitative factor deficiency test. The recall was initiated because a positive drift in quality control (QC) values was identified within the reagent's stated 4-hour onboard stability period.
The affected units were distributed nationwide in the United States, specifically in the states and territory of NJ, NY, VA, PA, FL, AL, GA, TN, OH, IL, MO, NE, TX, CO, UT, CA, and PR. The expiration date for the recalled lot is March 31, 2027.
Healthcare facilities and laboratories should stop using the affected reagent immediately and contact Diagnostica Stago for instructions on return or disposal. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
- Manufacturer
- Diagnostica Stago, Inc.
- Hazard
- Affected units
- 5,220
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746
- Exp 3/31/2027
Distribution
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