Class 2 Device Recall Serrated blade Applicator Kit (12 Sample)

• Date Initiated by Firm: May 02, 2023
• Date Posted: June 16, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1975-2023
• Recall Event ID: 92297
• Product Classification: Equipment, laboratory, general purpose, labeled or promoted for a specific medical use - Product Code LXG
• Product: Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
• Code Information: Lot # 3-22, UDI-DI: M5255526870
• FEI Number: 1618982
• Recalling Firm/ Manufacturer: Helena Laboratories, Corp.; 1530 Lindbergh Dr; Beaumont TX 77707-4131
• For Additional Information Contact: Dr. Jessica J. Hanka; 409-842-3714
• Manufacturer 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.
• FDA Determined Cause: Process design
• Action: On April 27, 2023, Helena Laboratories contacted consignees via phone to make them aware of the recall. On May 2, 2023, Helena Laboratories followed up by issuing an Urgent Medical device Recall notification via E-Mail. Helena Laboratories asks consignees to take the following actions: 1. Carefully open each box while wearing gloves. Do not touch the teeth of the applicator as this can affect its use during sample delivery. 2. Locate the number imprinted on the handle of the applicator. The number may face outward or inward depending on the placement in the box. Incorrect applicators are imprinted with the number 18. 3. Remove and discard any boxes with applicators imprinted with the number 18. If the applicator is imprinted with the number 12, mark the box to indicate that it has been examined and contains the correct product. 4. Notate the total number of boxes inspected on the attached form. Affected products will be credited or replaced. 5. If you have further distributed this product, please identify your customers and notify them at once of this recall. Your notification to your customers may include a copy of this recall notification letter. This recall should be carried out at the user level. 6. Please complete and return the enclosed Acknowledgement and Receipt Form to technicalservice@helena.com or mail.
• Quantity in Commerce: 32 units
• Distribution: Distribution to US states of PA, NE, MI, FL, AR, NY, TX, and CA, and to Thailand.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.