Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 16, 2019
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
The plates do not have wells punched for the controls in the patient 1 area.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Helena Laboratories, Corp. recalled SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name … - a moderate-severity action.
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name … was recalled by Helena Laboratories, Corp. in October 16, 2019. Reason: The plates do not have wells punched for the controls in the patient 1 area.. Check the official notice for the remedy. Verify recall #Z-0045-2020 with the FDA Devices before acting.
The recall
Helena Laboratories, Corp. issued this moderate-severity FDA Devices recall-The plates do not have wells punched for the controls in the patient 1 area..
- Moderate
- severity level
- Class II
- classification
- October 16, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0045-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0045-2020) was formally reported on October 16, 2019, with the manufacturer initiating the action on July 21, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Helena Laboratories, Corp. is listed as the recalling firm, operating out of Beaumont, TX. Federal records list the affected scope as 24 kits.
The documented reason for this recall is: The plates do not have wells punched for the controls in the patient 1 area. Distribution data in the federal record shows the product reached: Distribution was made to IN, KY, MA, OH, OR, TN, and TX. There was government distribution. Foreign distribution was made to Chile.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
24 kits
Related Recalls
6
3 from same agency
Product description
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Reason for recall
The plates do not have wells punched for the controls in the patient 1 area.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0045-2020 |
| Date reported | October 16, 2019 |
| Date initiated | July 21, 2017 |
| Recalling firm | Helena Laboratories, Corp. |
| Firm location | Beaumont, TX |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0045-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.. Recalled by Helena Laboratories, Corp.. Units affected: 24 kits.
Why was this product recalled? ▼
The plates do not have wells punched for the controls in the patient 1 area.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 16, 2019. Severity: Moderate. Recall number: Z-0045-2020.
Where was the recalled product distributed? ▼
Distribution: Distribution was made to IN, KY, MA, OH, OR, TN, and TX. There was government distribution. Foreign distribution was made to Chile..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0045-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 16, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.