Lower riskMedical device recall · FDA · Published May 2, 2023
Helena Serrated Blade Kit May Cause Incorrect Test Results
Helena Laboratories recalls serrated blade applicator kits for incorrect or delayed lab results due to missing samples. Affected kits may need replacement to ensure accurate testing.
Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result.
Take action
Contact the company
📍Recalling firmHelena Laboratories, Corp.1530 Lindbergh Dr · Beaumont, TX 77707-4131
“Helena Serrated Blade Kit May Cause Incorrect Test Results.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/58481-helena-serrated-blade-kit-may-cause-incorrect-test-results. Based on FDA recall #Z-1975-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1975-2023%22&limit=1).
The FDA announced on May 2, 2023, that Helena Laboratories, Corp. is recalling the Serrated Blade Applicator Kit (REF: 552687) because packaging may contain an incorrect blade type, leading to incorrect or no test results. This voluntary Class II recall affects 32 units distributed to several U.S. states and Thailand.
How to tell if you have it
Brand: Helena Laboratories
Product: Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system
Lot #: 3-22
UDI-DI: M5255526870
Quantity: 32 units
The hazard
Packaging for the serrated blade applicator kit may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result.
Context
GovInfoNow's records show Helena Laboratories, Corp. has had 8 other recalls since July 21, 2017, including a April 6, 2022 recall of the Helena V8 Immunodisplacement Kit for microbial growth and a Jan. 5, 2021 recall of the Cascade Abrazo aPTT Test Card for shorter clot times. Other recent recalls of similar products include Magellan LeadCare II Blood Lead Test Kits (March 13, 2026), Magellan LeadCare Plus Blood Lead Test Kit (March 13, 2026), and Magellan LeadCare Ultra Blood Lead Test Kit (March 13, 2026).
How to tell if you have this one
Check for the product name 'Serrated Blade Applicator Kit (12 Sample)', reference number 552687, and lot number 3-22. The kit is used with the Spife Nexus system for in vitro diagnostics.
Brand
Helena Laboratories
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the reference number 552687 and lot number 3-22 on the packaging.
Where it went and when
Where it was distributed
Distributed in 8 states.
Listed by the agency
Not listed
FDA distribution: “Distribution to US states of PA, NE, MI, FL, AR, NY, TX, and CA, and to Thailand.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arkansas, California, Florida, Michigan, Nebraska, New York, Pennsylvania, Texas.
Recall timeline
FDA published this recall 57 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1975-2023 (May 2, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1975-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.