Reported Jun 28, 2023 · Ongoing
Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade…
Helena Laboratories, Corp.
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: Helena Laboratories, Corp. · 1530 Lindbergh Dr · Beaumont, TX · 77707-4131
Is this the product you have?
- Serrated Blade Applicator Kit (12 Sample)
- REF552687, For use with the Spife Nexus system
- Contents30 Blade Applicators. used in invitro diagnostics
- Lot codes and dates
- Lot # 3-22
- UDI-DIM5255526870
- Amount recalled
- 32 units
Where it was sold
Why it was recalled
Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result.
This product could cause temporary or reversible health problems — stop using it.
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