Home › RANDOX LABORATORIES LIMITED › ALP
ALP
RANDOX LABORATORIES LIMITED · Model AP2809 · UDI-DI 05055273200300
CJE
Prescription
1
510(k) clearances
74
Adverse events
22
Recalls
37
Facilities
Description
The ALP method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of Alkaline Phosphatase (ALP) activity in serum or plasma.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.