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Terminated

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

FDA Recall Z-0045-2020 · Posted None

Recalling FirmHelena Laboratories, Corp.
Recall StatusTerminated
Product CodeCFF
Date Initiated2017-07-21
Date Terminated2020-06-19
Product Quantity24 kits

Reason for Recall

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

Firm 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.

Root Cause

Employee error

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K973040SPIFE IFE-6Helena Laboratories · 1998-01-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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