Z-1975-2023Class II

Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30...

Name: Z-1975-2023 Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30...
Creator: Helena Laboratories, Corp.
Published: 2023-05-02
License: https://open.fda.gov/license/

Helena Laboratories, Corp. / initiated 2023-05-02 / Open, Classified / root cause: manufacturing process

FDA source

Helena Laboratories, Corp. began a recall of Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics on 2023-05-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1975-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-02
Posted: 2023-06-16
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
Product code: LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
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.
Root cause tag: manufacturing process
FDA 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 [email protected] 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.
Product codes and lots: Lot # 3-22, UDI-DI: M5255526870

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1975-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1975-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-28	2023-06-16

Product code LXG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)