Facility

MICRO TYPING SYSTEMS, INC.

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

Key facts

1recalls · worst Class II

1inspections · worst VAI

—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)	1000132079
Establishment type	Manufacture Medical Device
Location	1295 SW 29TH AVE POMPANO BEACH, FL, US 33069
Registration status	Active · expires 2026
Parent company	QuidelOrtho Corporation (owner-operator 2024674)
Brand names	DAT Control, MTS DAT Card

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Kit, Quality Control For Blood Banking Reagents
Product code KSF (opens in a new tab) · Class II · Hematology · 21 CFR 864.9650

Recalls & enforcement

Class IIOngoing2024-04-09
T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment, and the results of ot…

FDA inspections (1)

VAI2016-01-15
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.

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. “MICRO TYPING SYSTEMS, INC. (FEI 1000132079) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000132079-micro-typing-systems-inc/

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