CLASS II ONGOING Device recall · Reported 15 Jun 2022 · FDA Enforcement Report

V8 Immunodisplacement Kit recalled by Helena Laboratories

Helena Laboratories is recalling V8 Immunodisplacement Kit, distributed in Florida, Missouri, Ohio, Texas. The recall was initiated on 6 Apr 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 1803 UDI Codes: +M52518030/SS73-21-1803/14D20230831Z +M52518030/SS71-21-1803/14D20230830X Lot 3-21-1803 Lot 1-22-1803
Quantity recalled51 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1244-2022
FDA event ID
90060
Recalling firm
Helena Laboratories, Beaumont, TX
Classification
Class II
Status
Ongoing
Recall initiated
6 Apr 2022
FDA classified
7 Jun 2022
Reported
15 Jun 2022
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

6 Apr 2022Recall initiated by company
7 Jun 2022Classified by FDA+62 days
15 Jun 2022Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to microbial growth causing interference with interpretation.

Product as listed by the FDA

V8 Immunodisplacement Kit REF 1803

Where it was distributed

U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,

FloridaMissouriOhioTexas

Questions about this recall

Is V8 Immunodisplacement Kit recalled?

Yes. Helena Laboratories recalled V8 Immunodisplacement Kit on 6 Apr 2022. The recall is Class II and its status is Ongoing. Recall number Z-1244-2022.

Why was it recalled?

Due to microbial growth causing interference with interpretation.

Which lots are affected?

Model Number: 1803 UDI Codes: +M52518030/SS73-21-1803/14D20230831Z +M52518030/SS71-21-1803/14D20230830X Lot 3-21-1803 Lot 1-22-1803

Where was it sold?

U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Helena Laboratories

All 16
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IISerrated Blade Applicator Kit (12 Sample) recalledHelena LaboratoriesPackaging Defects8 states
DeviceCLASS IICascade Abrazo aPTT Test Card recalled by Helena LaboratoriesHelena LaboratoriesOtherNationwide
DeviceCLASS IIK-act Actalyke Clotting Test Tubes that are used recalledHelena LaboratoriesDevice MalfunctionNationwide
DeviceCLASS IIICollagen Reagent recalled by Helena LaboratoriesHelena LaboratoriesParticulate Matter10 states
DeviceCLASS IIIPlatelet Aggregation Kit recalled by Helena LaboratoriesHelena LaboratoriesParticulate Matter10 states

Other Other Medical Devices recalls

All 13,771
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIMedline Convenience Kits: Blood Draw Kit recalled by Medline IndustriesMedline IndustriesSterilityNationwide
DeviceCLASS IIMedline Convenience Kits containing BD ChloraPrep Clear recalledMedline IndustriesLead & Heavy MetalsNationwide
DeviceCLASS IIMedline Convenience Kits: Ortho Aspiration Kit recalledMedline IndustriesSterilityNationwide
DeviceCLASS IIMedline Convenience Kits containing BD ChloraPrep DYKA1054F recalledMedline IndustriesLead & Heavy MetalsNationwide
DeviceCLASS IIMedline Convenience Kits: Arterial Line Insertion Kit recalledMedline IndustriesSterilityNationwide