Chembio Diagnostics, Inc FDA Record
Chembio Diagnostics, Inc has 3 FDA recalls, 0 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Chembio Diagnostics, Inc" is on file.
- Latest recall
- Z-2809-2020 · Class II · Jun 18, 2020
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 3 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2809-2020 | Class II | Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG System- Rapid… | Jun 18, 2020 |
| Z-2808-2020 | Class II | Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic… | Jun 18, 2020 |
| Z-2807-2020 | Class II | Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection… | Jun 18, 2020 |
Chembio Diagnostics, Inc and the FDA: common questions
Has Chembio Diagnostics, Inc received an FDA warning letter?
No FDA warning letter addressed to the name "Chembio Diagnostics, Inc" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Chembio Diagnostics, Inc received an FDA Form 483?
FDA has not published a Form 483 for "Chembio Diagnostics, Inc" in its reading room. FDA publishes some Form 483s, not all of them.
Has Chembio Diagnostics, Inc had an FDA recall?
Yes. Chembio Diagnostics, Inc has 3 FDA recalls on record. The most recent started Jun 18, 2020.
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