Recall Z-1975-2023 ยท LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
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
| Date | Jun 16, 2023 (initiated May 2, 2023) |
| Status | Open, Classified |
| 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 i |
| Quantity | 32 units |
| Distribution | Distribution to US states of PA, NE, MI, FL, AR, NY, TX, and CA, and to Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.