CLASS II ONGOING Device recall · Reported 9 Sep 2026 · FDA Enforcement Report
STA Staclot Protein recalled by Diagnostica Stago
Diagnostica Stago is recalling STA Staclot Protein S, distributed nationwide in the US. The recall was initiated on 29 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3047-2026
- FDA event ID
- 99531
- Recalling firm
- Diagnostica Stago, Parsippany, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Jul 2026
- FDA classified
- 28 Aug 2026
- Reported
- 9 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 29 Jul 2026 | Recall initiated by company | |
| 28 Aug 2026 | Classified by FDA | +30 days |
| 9 Sep 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
Where it was distributed
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.
Nationwide AlabamaCaliforniaColoradoFloridaGeorgiaIllinoisMissouriNebraskaNew JerseyNew YorkOhioPennsylvaniaPuerto RicoTennesseeTexasUtahVirginia
Questions about this recall
Why was it recalled?
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
Which lots are affected?
UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Diagnostica Stago
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Liatest D-Di recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | STA Liatest Free Protein recalled by Diagnostica Stago | Diagnostica Stago | Device Malfunction | Nationwide |
| Device | CLASS II | Asserachrom HPIA recalled by Diagnostica Stago | Diagnostica Stago | Device Malfunction | Nationwide |
| Device | CLASS II | STA Liatest D-Di recalled by Diagnostica Stago | Diagnostica Stago | Other | Nationwide |
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