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Biobase Biodustry(Shandong)Co., Ltd. · Model R1:70mL×2 R2:14mL×2 · UDI-DI 06971674862932
10
510(k) clearances
1
Adverse events
5
Recalls
24
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-10 | Ortho-Clinical Diagnostics, Inc. | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are use |
| 2025-06-10 | Ortho-Clinical Diagnostics, Inc. | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are use |
| 2025-06-10 | Ortho-Clinical Diagnostics, Inc. | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are use |
| 2025-06-10 | Ortho-Clinical Diagnostics, Inc. | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are use |
| 2013-06-12 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.