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BIOBASE
Biobase Biodustry(Shandong)Co., Ltd. · Model R:20mL×8 · UDI-DI 06971674865124
10
510(k) clearances
113
Adverse events
8
Recalls
37
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-03 | Beckman Coulter Inc. | Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient |
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur |
| 2013-08-12 | Abbott Laboratories, Inc | Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates assigned by Supplier. |
| 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. |
| 2013-02-22 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(R) Reagent due to reagent interaction causing falsely depressed Creatinine results |
| 2012-10-10 | Alfa Wassermann, Inc. | Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results. |
| 2010-05-04 | Abbott Laboratories Inc. | Product may give inaccurate results and aspiration errors with reagent configuration, including results outside of linear range & calibration failure. |
| 2007-01-30 | Abbott Laboratories Inc. | Patient results are falsely decreased by up to 15% at these levels: 1) Serum Plasma phosphorus greater than 8.0 mg/dL (2.60 mmol/L) 2) Urine phosphorus greater than 80.0 mg/dL (25. |
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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.