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Pointe Scientific, Inc.
HORIBA INSTRUMENTS INCORPORATED · Model HA916-302 · UDI-DI 00811727012876
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 on Hitachi analyzers. For in vitro diagnostic use only. Size: 5 x 50mL, 4 x 13mL
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.