Siemens Healthcare Diagnostics, Inc: Calibration failures and/or significant negative shifts in quality control (QC) and patient results.

Agency Publication Date: September 10, 2013

Affected Products

Product: ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.

22288218, 22296218, 222907218

Product: ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.

22289218, 22297218, 22535218

Product: ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.

22298218

Product: ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.

22299218

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 65806

Status: Resolved

Manufacturer: Siemens Healthcare Diagnostics, Inc

Manufactured In: United States

Units Affected: 4 products (3114; 2840; 488; 44)

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Sources: FDA iRES · Raw API Response

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