FDA Medical Device Recalls (openFDA)
Helena Laboratories, Corp.: SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
- Recall number
- Z-0045-2020
- 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.
- Status
- Terminated
- Initiated
- 2017-07-21
- Posted
- not on file
- Terminated
- 2020-06-19
- Reason
- The plates do not have wells punched for the controls in the patient 1 area.
- 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
- 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.
- Lot, serial or model codes
- Lot 35-17-552583, exp. date 4/30/2018
- 510(k) numbers
- ["K973040"]
- PMA numbers
- not on file
- Product code
- CFF
- Firm FEI
- 1618982
- Firm city
- Beaumont
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28