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Synermed®

INFRARED LABORATORY SYSTEMS LLC · Model VI120-911 · UDI-DI 05060500090104

CJE Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

AMP Alkaline Phosphatase Reagent 4 X 50 mL + 4 powder vials

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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Data 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.