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STAT-Site WB Blood Glucose Test Strips

STANBIO LABORATORY, L.P. · Model 7010-100 · UDI-DI 00657498002216

LFR Prescription

510(k) clearances

74,282

Adverse events (33 deaths)

Recalls

Facilities

Description

The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary, venous and neonatal capillary heelstick whole blood samples. It should not be used for the diagnosis of or screening for diabetes.

Recalls

Date	Firm	Reason
2021-07-28	Roche Diabetes Care, Inc.	Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate
2021-07-28	Roche Diabetes Care, Inc.	Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate
2018-05-07	Roche Diabetes Care, Inc.	The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a bloo
2018-05-07	Roche Diabetes Care, Inc.	The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a bloo
2018-05-07	Roche Diabetes Care, Inc.	The recalling firm identified four US lots of test strips out of specification. Affected strips show increased potential for strip errors prior to applying blood, strips not detect
2016-02-11	Roche Diagnostics Operations, Inc.	Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the communication between the meter and the Data Management Systems (DMS). The
2012-02-21	Lifescan Inc	An error was discovered in the OneTouch IQ meter software so that the meter turns itself off when a user attempts to view results in the "Results Log" when the log has 256 or a mul
2011-08-12	Bayer Healthcare, LLC	All 10- or 25- count glucose test strip vials, either loose vials or found in patient starter kits of Contour, Contour TS and Contour" USB blood glucose meters are being recalled a
2009-05-13	Roche Diagnostics Corp.	The lancet cap may be missing, which could result in an unintended lancet stick to the user.
2009-05-13	Roche Diagnostics Corp.	The lancet cap may be missing, which could result in an unintended lancet stick to the user.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.