Lower risk Medical device recall · FDA · Published February 27, 2018

Helena Laboratories SPIFE Alkaline Hemoglobin Kit Recall: Incorrect Instructions May Cause

Helena Laboratories recalls SPIFE Alkaline Hemoglobin Kit (Cat. No. 3415) due to outdated instructions that could lead to incorrect results. Affected lots include specific 2017 and 2018 production batches with expiration dates up to December 31, 2018.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0297-2020Medical device Helena Laboratories ›

Lower-risk recall

Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users.

Take action

Contact the company

Recalling firmHelena Laboratories, Corp.1530 Lindbergh Dr · Beaumont, TX 77707-4131

✎ GovInfoNow plain-language explainer

Helena Laboratories is recalling their SPIFE Alkaline Hemoglobin Kit (Cat. No. 3415) because some versions contain outdated instructions that reference new electrodes not yet available to users. This could lead to incorrect hemoglobin measurements if used without the proper updated equipment. Read more at govinfonow.com/recall/71861-helena-laboratories-spife-alkaline-hemoglobin-kit-recall-incorrect-instructions-may.

Source Summary by GovInfoNow · govinfonow.com/recall/71861-helena-laboratories-spife-alkaline-hemoglobin-kit-recall-incorrect-instructions-may · Updated August 27, 2026 · FDA enforcement record: FDA #Z-0297-2020

Cite this page

“Helena Laboratories SPIFE Alkaline Hemoglobin Kit Recall: Incorrect Instructions May Cause.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71861-helena-laboratories-spife-alkaline-hemoglobin-kit-recall-incorrect-instructions-may. Based on FDA recall #Z-0297-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0297-2020%22&limit=1).

The FDA announced on 2018-02-27 that Helena Laboratories, Corp. is recalling SPIFE Alkaline Hemoglobin Kits for containing incorrect Customer Procedures instructions. The agency stated the error could lead to misinterpretation of test results.

How to tell if you have it

Brand: Helena Laboratories
Product: SPIFE Alkaline Hemoglobin Kit
Catalog No.: 3415
Lot Codes: 62-17-551977, 63-17-551977, 64-17-551977, 65-17-551977, 66-17-551977, 67-17-551977, 68-17-551977, 69-17-551977, 70-17-551977, 71-17-551977, 72-17-551977, 1-18-551977, 2-18-551977, 3-18-551977, 4-18-551977, 5-18-551977, 6-18-551977, 7-18-551977, 8-18-551977, 9-18-551977, 10-18-551977, 11-18-551977, 12-18-551977, 13-18-551977

The hazard

The FDA said the lots contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes that have not yet been made available to users.

Context

GovInfoNow's records show Helena Laboratories, Corp. has had 8 other recalls since 2017-07-21. Other recent recalls of similar products include Helena Serrated Blade Kit May Cause Incorrect Test Results (2023-05-02), Helena V8 Immunodisplacement Kit Recall: Microbial Growth Causes Interpretation Errors (2022-04-06), and Helena Laboratories Cascade Abrazo aPTT Test Card Recall: Shorter Clot Times Risk (2021-01-05). Other recent recalls of similar products include Aniara Diagnostica ZYMUTEST HIA IgG Kit Recall: Incorrect Positive Control Values (2026-04-01), Diagnostica Stago Asserachrom HPIA Kit Recall: False Negative Results Risk (2025-12-15), and Boston Scientific FARASTAR PFA Generator Recall: Labeling Issue With Catheter Instructions (2026-06-11).

How to tell if you have this one

Check the lot code on the kit, which is listed as 62-17-551977 through 13-18-551977. The kit was manufactured in 2017 or 2018 with specific expiration dates up to December 31, 2018.

Brand
Helena Laboratories
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Code
Look for the lot code on the kit, which ranges from 62-17-551977 to 13-18-551977.

Where it went and when

Where it was distributed

Distributed in 22 states, and outside the U.S.

FDA distribution: “US: OH, NY, MI, IN, IL, MS, TX, CT, NJ, KY, FL, MD, GA, PA, AZ, MO, VA, SC, LA, KS, WA, WI, OUS: Colombia, Brasil, Taiwan” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Missouri, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 20 months after the firm started it.

Feb 27, 2018Firm started the recall
Nov 5, 2019FDA classified it Class III
Nov 13, 2019Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/71861-helena-laboratories-spife-alkaline-hemoglobin-kit-recall-incorrect-instructions-may">Helena Laboratories SPIFE Alkaline Hemoglobin Kit Recall: Incorrect Instructions May Cause (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0297-2020 (February 27, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0297-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.