Reported Nov 11, 2020 · Terminated
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
Primus Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Primus Corporation · 4231 E 75th Ter · Kansas City, MO · 64132-2059
Is this the product you have?
- Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
- Lot codes and dates
- Product Name and Product Code ultra2 Resolution Variants Analyzer / 03-01-0047 ultra2 Resolution Analytical Column / 01-05-0011 Resolution Analytical Column / 01-05-0015 FASC Position Marker / 01-04-0042 A2+F Control Material Kit / 01-04-0043 Mobile Phase 1 Reagent 3.8L / 01-03-0040 Mobile Phase 1 Reagent 940mL / 01-03-0042 Mobile Phase 2 Reagent 3.8L / 01-03-0041 Mobile Phase 2 Reagent 940mL / 01-03-0044 2 Diluent Reagent 3.8L / 01-03-0056 2 Diluent Reagent 940mL / 01-03-0059 System Wash Reagent / 01-03-0035
- Analyzer Unit serial numbers
97 of 97 codes
100242100314100331100354100468100541100638100746100243100316100332100355100485100551100639100747100244100317100334100356100492100558100644100751100245100319100335100357100501100559100645100758100300100321100337100358100503100561100654100765100301100322100338100359100507100562100660100802100304100323100342100360100508100563100664100305100324100343100361100510
- Amount recalled
- 97 devices (USA only)
Where it was sold
Why it was recalled
The product did not receive pre-market approval or clearance.
This product could cause temporary or reversible health problems — stop using it.
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