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Pointe Scientific, Inc.
HORIBA INSTRUMENTS INCORPORATED · Model HA716-2400 · UDI-DI 00811727014597
CJE
Prescription
1
510(k) clearances
74
Adverse events
22
Recalls
37
Facilities
Description
Alkaline Phosphatase Reagent, for the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. Size: 1 x 2 L, 1 x 400 mL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2023-08-05 | Ortho-Clinical Diagnostics, INc. | Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate de |
| 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. |
| 2011-08-26 | Abbott Laboratories, Inc | The reagent has the potential to be contaminated with mold, the Cladosporium fungal species. |
| 2008-02-07 | Pointe Scientific, Inc. | May be contaminated with microorganisms. |
| 2008-02-07 | Pointe Scientific, Inc. | May be contaminated with microorganisms. |
| 2008-02-07 | Pointe Scientific, Inc. | May be contaminated with microorganisms. |
| 2008-02-07 | Pointe Scientific, Inc. | May be contaminated with microorganisms. |
| 2008-02-07 | Pointe Scientific, Inc. | May be contaminated with microorganisms. |
| 2008-02-07 | Pointe Scientific, Inc. | May be contaminated with microorganisms. |
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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.