CLASS II ONGOING Device recall · Reported 28 Jun 2023 · FDA Enforcement Report

Serrated Blade Applicator Kit (12 Sample) recalled

Helena Laboratories is recalling Serrated Blade Applicator Kit (12 Sample), distributed in 8 states. The recall was initiated on 2 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 3-22, UDI-DI: M5255526870

Quantity recalled32 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1975-2023
FDA event ID: 92297
Recalling firm: Helena Laboratories, Beaumont, TX
Classification: Class II
Status: Ongoing
Recall initiated: 2 May 2023
FDA classified: 16 Jun 2023
Reported: 28 Jun 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Test Kits & Diagnostics

Timeline

2 May 2023	Recall initiated by company
16 Jun 2023	Classified by FDA	+45 days
28 Jun 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

Distribution to US states of PA, NE, MI, FL, AR, NY, TX, and CA, and to Thailand.

Arkansas California Florida Michigan Nebraska New York Pennsylvania Texas

Questions about this recall

Is Serrated Blade Applicator Kit (12 Sample) recalled?

Yes. Helena Laboratories recalled Serrated Blade Applicator Kit (12 Sample) on 2 May 2023. The recall is Class II and its status is Ongoing. Recall number Z-1975-2023.

Why was it recalled?

Which lots are affected?

Lot # 3-22, UDI-DI: M5255526870

Where was it sold?

Distribution to US states of PA, NE, MI, FL, AR, NY, TX, and CA, and to Thailand.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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