Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported April 15, 2015
Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial (0.5ml) for feces test 4. Swab for Nasal test.
LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, app…
Lusys Laboratories, Inc. recalled Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device … — a critical-severity action.
Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device … was recalled by Lusys Laboratories, Inc. in April 15, 2015. Reason: LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devic…. Check the official notice for the remedy. Verify recall #Z-1334-2015 with the FDA Devices before acting.
The recall
Lusys Laboratories, Inc. issued this critical-severity FDA Devices recall — LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devic….
- Critical
- severity level
- 5 units
- affected scope
- Class I
- classification
- April 15, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1334-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1334-2015) was formally reported on April 15, 2015, with the manufacturer initiating the action on March 13, 2015. It is classified under Critical severity (Class I), with a current status of Terminated. Lusys Laboratories, Inc. is listed as the recalling firm, operating out of San Diego, CA. Federal records list the affected scope as 5 units.
The documented reason for this recall is: LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagn… Distribution data in the federal record shows the product reached: Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.. 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, 6 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
5 units
Related Recalls
6
6 from same agency
Product description
Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial (0.5ml) for feces test 4. Swab for Nasal test.
Reason for recall
LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1334-2015 |
| Date reported | April 15, 2015 |
| Date initiated | March 13, 2015 |
| Recalling firm | Lusys Laboratories, Inc. |
| Firm location | San Diego, CA |
| Affected scope | 5 units |
| Distribution | Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark. |
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-1334-2015) 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.
- This is a Class I (high-risk) recall — stop using the product immediately and follow the disposal or return instructions. 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? ▼
Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial (0.5ml) for feces test 4. Swab for Nasal test.. Recalled by Lusys Laboratories, Inc.. Units affected: 5 units.
Why was this product recalled? ▼
LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 15, 2015. Severity: Critical. Recall number: Z-1334-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1334-2015) 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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What to do next
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported April 15, 2015.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.