Recall Z-1975-2023— Helena Laboratories, Corp.
Class II · Ongoing
Class II FDA medical device recall by Helena Laboratories, Corp., initiated 2023-05-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics. Reason: 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..
- Recalling firm
- Helena Laboratories, Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-02
- Firm location
- Beaumont, TX, United States
Product description
Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.