STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor defi
Summary
The FDA issued a Class II for STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; by Diagnostica Stago, Inc.. Reason: A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified.
Details
Source
Device Recall
External ID
Z-3047-2026
Action Date
2026-09-09
Status
Ongoing
Category
device
Product Description
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
Lot/Code Info: UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027
Quantity Affected: 5220 units
Reason for Recall
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-29
Company
Parsippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Diagnostica Stago, Inc. has 15 FDA actions in our database, including 13 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Diagnostica Stago, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Diagnostica Stago, Inc. have FDA actions?
Diagnostica Stago, Inc. has 15 FDA actions in our database, including 13 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3047-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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