Facility

JAS Diagnostics/Drew Scientific

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

Key facts

1recalls · worst Class II

3inspections · worst OAI

1warning letters

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

FDA Establishment Identifier (FEI)	3003071743
Establishment type	Manufacture Medical Device
Location	6600 NW 14th Street Plantation, FL, US 33313
Registration status	Active · expires 2026
Parent company	JAS Diagnostics/Drew Scientific (owner-operator 9042128)
Brand names	Differential Lyse (20L); Drew 3 Reagent Pac; Drew-3 Lytic Reagent; EX-Lyse; EX-PAC2

Activity by year

Recalls (1)
Inspections (3)
Warning letters (1)

Devices registered here (1)

Products, Red-Cell Lysing Products
Product code GGK (opens in a new tab) · Class I · Hematology · 21 CFR 864.8540

Recalls & enforcement

Class IITerminated2016-03-10
The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check.

FDA inspections (3)

OAI2025-06-12
Official Action Indicated · Compliance: Devices · citations posted
OAI2022-04-28
Official Action Indicated · Compliance: Devices · citations posted
VAI2019-08-29
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Warning Letter2022-08-16
Warning Letter (opens in a new tab) · Miami Lakes Florida

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by JAS Diagnostics/Drew Scientific

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. “JAS Diagnostics/Drew Scientific (FEI 3003071743) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003071743-jas-diagnostics-drew-scientific/

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