Facility

EXACT DIAGNOSTICS

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

Key facts

6recalls · worst Class II

1inspections · worst NAI

—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)	3011926203
Establishment type	Manufacture Medical Device
Location	100 South Jones Street Suite #100 Fort Worth, TX, US 76104
Registration status	Active · expires 2026
Parent company	Bio-Rad Laboratories, Inc. (owner-operator 9929003)
Brand names	Exact Diagnostics CMV 1E3 IU/mL Precision [CMVL201]; Exact Diagnostics HSV-1 Verification Panel [HSV1P100]; Exact Diagnostics JCV Verification Panel [JCVP100]; Exact Diagnostics HCV Verification Panel [HCVP100]; Exact Diagnostics Parvovirus B19 Verification Panel [B19P100]; Exact Diagnostics HBV 1E3 IU/mL Precision [HBVL201]; Exact Diagnostics HSV-2 Verification Panel [HSV2P100]; Exact Diagnostics EBV Verification Panel [EBVP100]; Exact Diagnostics CT/NG Verification Panel [CTNGP200]; Exact Diagnostics HIV-1 1E5 cp/mL Precision [HIVH202]; Exact Diagnostics BKV Verification Panel [BKVP100]; Exact Diagnostics HIV-1 Verification Panel 1.4 mL [HIVP200]

Activity by year

Recalls (6)
Inspections (1)

Devices registered here (1)

Calibrator, Secondary
Product code JIT (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1150

Recalls & enforcement

Class IIOngoing2022-04-07
The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number: 250-3020, included in VARIANT nbs Sickle Cell Progam Reorder Pack #250-3000. This CD-ROM software included in specific lots of VARIANT nbs Sickle Cell Progam Reorder Pack c…
Class IITerminated2015-12-15
On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration.
Class IITerminated2014-04-08
There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used.
Class IITerminated2014-02-27
On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample.
Class IIITerminated2013-11-22
D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Hemoglobin Testing System.
Class IIITerminated2013-04-15
The Liquichek" ToRCH Plus IgM Control - Positive, contains detectable levels of HCV RNA which originated from the non-specific human IgM component used in the mouse monoclonal antibody conjugation process for this product.

FDA inspections (1)

NAI2019-06-04
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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.

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. “EXACT DIAGNOSTICS (FEI 3011926203) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011926203-exact-diagnostics/

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