CLASS I Device recall · Reported 15 Apr 2015 · FDA Enforcement Report
Ebola GP IgX Blood, Serum, Plasma, Cassette recalled
Lusys Laboratories is recalling Ebola GP IgX Blood, Serum, Plasma, Cassette, distributed in California. The recall was initiated on 13 Mar 2015 and the FDA has classified it as Class I.
Check your package
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-1329-2015
- FDA event ID
- 70668
- Recalling firm
- Lusys Laboratories, San Diego, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 13 Mar 2015
- FDA classified
- 9 Apr 2015
- Reported
- 15 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 13 Mar 2015 | Recall initiated by company | |
| 9 Apr 2015 | Classified by FDA | +27 days |
| 15 Apr 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged separately, and sufficient for use with up to 40 tests.
Where it was distributed
Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
Questions about this recall
Why was it 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 lots are affected?
Lot No. 12012014B
Where was it sold?
Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 70668More recalls from Lusys Laboratories
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Covid-19 IgG/Igm Antibody Test For Detection of Covid recalled | Lusys Laboratories | Other | Nationwide |
| Device | CLASS I | LuSys 2nd Generation of Covid-19 Viral Antigen Test For all recalled | Lusys Laboratories | Other | Nationwide |
| Device | CLASS I | Luscient Diagnostics 2nd Generation of Covid-19 Viral recalled | Lusys Laboratories | Other | Nationwide |
| Device | CLASS I | Ebola GP IgM Blood (Blood Serum/Plasma/Cassette) recalled | Lusys Laboratories | Other | CA |
| Device | CLASS I | Ebola Accessories assembled, self-contained package recalled | Lusys Laboratories | Packaging Defects | CA |
Other Insulin Pumps & Glucose Monitors recalls
All 459| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Device Malfunction | CA |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Packaging Defects | Nationwide |