CLASS II Device recall · Reported 16 Oct 2019 · FDA Enforcement Report

Spife ImmunoFix-6 Kit recalled by Helena Laboratories

Helena Laboratories is recalling Spife ImmunoFix-6 Kit, distributed in 7 states. The recall was initiated on 21 Jul 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 35-17-552583, exp. date 4/30/2018

Quantity recalled24 kits

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-0045-2020
FDA event ID: 83622
Recalling firm: Helena Laboratories, Beaumont, TX
Classification: Class II
Status: Terminated
Recall initiated: 21 Jul 2017
FDA classified: 4 Oct 2019
Reported: 16 Oct 2019
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

21 Jul 2017	Recall initiated by company
4 Oct 2019	Classified by FDA	+805 days
16 Oct 2019	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

The plates do not have wells punched for the controls in the patient 1 area.

Product as listed by the FDA

SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

Where it was distributed

Distribution was made to IN, KY, MA, OH, OR, TN, and TX. There was government distribution. Foreign distribution was made to Chile.

Indiana Kentucky Massachusetts Ohio Oregon Tennessee Texas

Questions about this recall

Is Spife ImmunoFix-6 Kit recalled?

Yes. Helena Laboratories recalled Spife ImmunoFix-6 Kit on 21 Jul 2017. The recall is Class II and its status is Terminated. Recall number Z-0045-2020.

Why was it recalled?

The plates do not have wells punched for the controls in the patient 1 area.

Which lots are affected?

Lot 35-17-552583, exp. date 4/30/2018

Where was it sold?

Distribution was made to IN, KY, MA, OH, OR, TN, and TX. There was government distribution. Foreign distribution was made to Chile.

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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