Facility

Sekisui Diagnostics P.E.I. Inc.

6 recall(s) on record — most severe on record: Class II.

Key facts

6recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3002806809
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer); Manufacture Medical Device
Location	70 Watts Avenue CHARLOTTETOWN Prince Edward Island, CA C1E 2B9
Registration status	Active · expires 2026
Parent company	Sekisui Diagnostics, LLC (owner-operator 10035388)
Brand names	Amylase Assay; Liquid Select Amylase Reagent; a-Amylase Test Reagent

Activity by year

Recalls (6)

Devices registered here (1)

Catalytic Methods, Amylase
Product code JFJ (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1070

Recalls & enforcement

Class IITerminated2016-11-29
Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.
Class IITerminated2016-01-22
Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover
Class IITerminated2013-09-16
Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin A/B Test Kit, because it has been determined that there is potential for false negative results.
Class IITerminated2012-10-24
Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standard reducing the slope of the standard curve requiring more frequent sample dilutions.
Class IITerminated2012-08-28
SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions.
Class IITerminated2012-05-29
Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Sekisui Diagnostics P.E.I. Inc. (FEI 3002806809) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002806809-sekisui-diagnostics-p-e-i-inc/

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