FDA Medical Device Recalls (openFDA)
Helena Laboratories, Corp.: Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
- Recall number
- Z-1975-2023
- Recalling firm
- Helena Laboratories, Corp.
- Product
- Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
- Status
- Open, Classified
- Initiated
- 2023-05-02
- Posted
- 2023-06-16
- Terminated
- not on file
- 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.
- Root 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
- 32 units
- Distribution
- Distribution to US states of PA, NE, MI, FL, AR, NY, TX, and CA, and to Thailand.
- Lot, serial or model codes
- Lot # 3-22, UDI-DI: M5255526870
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXG
- Firm FEI
- 1618982
- Firm city
- Beaumont
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28