Z-0045-2020Class II

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

Name: Z-0045-2020 SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is...
Creator: Helena Laboratories, Corp.
Published: 2017-07-21
License: https://open.fda.gov/license/

Helena Laboratories, Corp. / initiated 2017-07-21 / Terminated / root cause: manufacturing process

FDA source

Helena Laboratories, Corp. began a recall of SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX on 2017-07-21. FDA classified it as Class II and gives the reason as "The plates do not have wells punched for the controls in the patient 1 area". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0045-2020
Classification: Class II
Status: Terminated
Initiated: 2017-07-21
Posted: 2019-10-04
Terminated: 2020-06-19
Recalling firm: Helena Laboratories, Corp.
Product: SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Product code: CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Reason for recall: The plates do not have wells punched for the controls in the patient 1 area.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The recall was initiated via phone on 7/21/2017 requesting the customer return the product for replacement if they routinely use the control wells.
Quantity in commerce: 24 kits
Distribution: Distribution was made to IN, KY, MA, OH, OR, TN, and TX. There was government distribution. Foreign distribution was made to Chile.
Product codes and lots: Lot 35-17-552583, exp. date 4/30/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0045-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0045-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-04

Product code CFF

K973040Class IISpife Ife-6Helena Laboratories / cleared 1998-01-02

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)