Electrode, Ion Based, Enzymatic, Creatinine

ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.

transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

Crea A and B membranes, packaged 4 per box

Negative drift on QC during in-use lifetime of CREA membranes can be observed.

S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj Denmark

When the user activates the dosicap (containing the crea additive) and mounts it onto the bottle, the threads will not seal correctly causing approximately 10% of the solution to leak out when the bottle is placed horizontally for dissolving the additive. This will cause the concentration of creatinin and creatin in the calibration solution to be wrong, and results in a bias on the Crea results.

i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ.

The i-STAT CREA Cartridges may produce inaccurate (depressed) results at or near the end of the labeled expiry date when stored above 25 degrees for 2 weeks.

Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 with Creatinine modules (8x7). The device is packa

Analysis of customer data, (for ABL 8X7 customers) has shown that the reference membranes are out of analytical specifications when replaced as specified in the device labeling. These errors in analytical specifications could lead to inadequate or clinical interventions (therapy) or misleading interpretation of patient status in clinical settings.

Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer

Erroneous, low creatinine results on CCX analyzer

Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2

Incorrect Results - Creatinine results were lower than the laboratory reference method.

Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical, Waltham, MA 02454

Incorrect Results - Creatinine results were lower than the laboratory reference method.

Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454

Incorrect Results - Creatinine results were lower than the laboratory reference method.