CLASS II Device recall · Reported 24 Feb 2021 · FDA Enforcement Report
AntIbody to Sars-CoV recalled by Sky Medical Supplies and
Sky Medical Supplies and Equipments is recalling AntIbody to Sars-CoV-2, distributed nationwide in the US. The recall was initiated on 19 Jan 2021 and the FDA has classified it as Class II.
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-1127-2021
- FDA event ID
- 87300
- Recalling firm
- Sky Medical Supplies and Equipments, Doral, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jan 2021
- FDA classified
- 16 Feb 2021
- Reported
- 24 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 19 Jan 2021 | Recall initiated by company | |
| 16 Feb 2021 | Classified by FDA | +28 days |
| 24 Feb 2021 | Published 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
Distributed COVID test kits without emergency use authorization.
Product as listed by the FDA
AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies and Equipments, LLC.
Where it was distributed
Worldwide distribution - US Nationwide distribution in the state of Florida and the country of Peru.
Questions about this recall
Why was it recalled?
Distributed COVID test kits without emergency use authorization.
Which lots are affected?
2020042901
Where was it sold?
Worldwide distribution - US Nationwide distribution in the state of Florida and the country of Peru.
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 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.
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