Teco Diagnostics: Henry Schein, Inc. OneStep Pro Urine Analyzer, Catalog Number: OneStep Pro Urine Analyzer The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10.

Recall number

Z-0580-2011

Recalling firm

Teco Diagnostics

Product

Henry Schein, Inc. OneStep Pro Urine Analyzer, Catalog Number: OneStep Pro Urine Analyzer The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10.

Status

Terminated

Initiated

2010-10-01

Posted

2010-12-09

Terminated

2012-08-03

Reason

This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di

Root cause

Other

Action

Teco Diagnostics initiated an "Urgent: Medical Device Recall" letter dated October 14, 2010, with an attached "Recall Return Response Form" to the affected consignees via US Postal on October 15, 2010. The recall notice informed the consignees of the reason for recall, the products affected and the actions required. Consignees were instructed to complete and return the enclosed Recall Return Response Form as soon as possible via mail, fax, or email. Upon receipt of the Recall Return Response Form, Teco Diagnostics would work with the consignees/distributors to process any refunds or reimbursements for the returned product and return shipping. If consignees/distributor had questions, they were to call Teco's Technical Support Department at (800) 222-9880 or (714) 463-1111.

Quantity

not on file

Distribution

Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, AND WV and the country of Canada.

Lot, serial or model codes

All units sold (2005 - 2010)

510(k) numbers

not on file

PMA numbers

not on file

Product code

KQO

Firm FEI

1832216

Firm city

Anaheim

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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