Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

Access Total T4 Calibrator, Catalog No. 33805

Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.

Access Total T4, REF 33800, IVD, thyroxine reagent assay.

Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.

T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only

Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.

VITROS TT4 Calibrator

Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.

Access Immunoassay Systems Total T4 Calibrators,

The recall was initiated because Beckman Coulter has confirmed that the stability claims for the Access Total T4 calibrators may not be met. This issue is associated with calibrator lots 917074 and 008534.

Access Total T4 Reagent Kit, Part Number: 33800,

The recall was initiated because the concentration of total T4 in samples from pregnant women is erroneously low (20%) when measured using the Access Total T4 assay. Erroneously low results which are actually high (outside of the normal reference range) could mask hyperthyroidism. Failure to diagnose or treat hyperthyroid disease associated with pregnancy could result in serious, permanent harm

VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.

Potential for positively biased results in QC and patient samples.

Total Thyroxine (T4) ELISA; REF EIA-1781

Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples.

Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.

VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468

The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.