Spotchem Ii Chemistry Basic 1 and Chemistry Basic 2 Tests

• • Terminated Z-0631-2016 FDA Class I ·initiated 18 Dec 2015 ·via K053401, on the same 510(k)

  One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K053401 ↗

FDA Product Code

CIC

Device Class

Class II

Regulation

21 CFR Part 862.1145

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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