Severity
Low
LowClass IIIOngoing
FDA Devices recall · Reported November 13, 2019
SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Helena Laboratories, Corp. recalled SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitat… - a low-severity action.
SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitat… was recalled by Helena Laboratories, Corp. in November 13, 2019. Reason: Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorr…. Check the official notice for the remedy. Verify recall #Z-0297-2020 with the FDA Devices before acting.
The recall
Helena Laboratories, Corp. issued this low-severity FDA Devices recall-Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorr….
- Low
- severity level
- Class III
- classification
- November 13, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0297-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0297-2020) was formally reported on November 13, 2019, with the manufacturer initiating the action on February 27, 2018. It is classified under Low severity (Class III), with a current status of Ongoing. Helena Laboratories, Corp. is listed as the recalling firm, operating out of Beaumont, TX. Federal records list the affected scope as 899 kits.
The documented reason for this recall is: 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 availab… Distribution data in the federal record shows the product reached: 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. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
899 kits
Related Recalls
6
3 from same agency
Product description
SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems
Reason for 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | Z-0297-2020 |
| Date reported | November 13, 2019 |
| Date initiated | February 27, 2018 |
| Recalling firm | Helena Laboratories, Corp. |
| Firm location | Beaumont, TX |
| Affected scope | 899 kits |
| 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 |
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-0297-2020) 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 Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems. Recalled by Helena Laboratories, Corp.. Units affected: 899 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2019. Severity: Low. Recall number: Z-0297-2020.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0297-2020) 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 November 13, 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.