Serrated Blade Applicator Kit packaging may contain wrong applicator size
Packaging for Helena Laboratories' Serrated Blade Applicator Kit (REF 552687) may contain the wrong applicator size (18-sample instead of 12-sample), causing incorrect or delayed diagnostic results in laboratory testing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II diagnostic device with a packaging error causing incorrect or delayed test results. While no illnesses or injuries have been reported, the potential for misdiagnosis in clinical lab settings represents significant risk-of-harm.
Plain-English summary
Helena Laboratories, Corp. is recalling Serrated Blade Applicator Kits (12 Sample, REF 552687) due to a packaging error. The packaging may contain an 18-sample applicator instead of the labeled 12-sample applicator.
When the incorrect applicator is used with the Spife Nexus system for in vitro diagnostics, it produces a characteristic pattern of missed or light samples on the gel. This results in incorrect laboratory results, no results, or delayed results—potentially affecting patient care.
The recall affects 32 units distributed to Pennsylvania, Nebraska, Michigan, Florida, Arkansas, New York, Texas, California, and Thailand. The affected lot is #3-22 (UDI-DI: M5255526870). If you have received this product, stop using it and contact Helena Laboratories, Corp. for a replacement.
The recalled product
- Product
- Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
- Manufacturer
- Helena Laboratories, Corp.
- Hazard
- packaging-error
- incorrect-results
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)
- Lot # 3-22
- UDI-DI: M5255526870
Distribution
Distributed in 8 states:
- AR
- CA
- FL
- MI
- NE
- NY
- PA
- TX
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