Beckman Coulter Inc.: Medical Device Recall in 2012 - (Recall #: Z-2227-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0 ng/mL.

Product Classification:

Class III

Date Initiated: October 11, 2011

Date Posted: August 29, 2012

Recall Number: Z-2227-2012

Event ID: 62791

Reason for Recall:

A recall was initiated because Beckman Coulter has identified a negative bias in test results when comparing elevated Total T3 patient samples diluted with Sample Diluent A to samples diluted with Access Total T3 Calibrator S0.

Status: Terminated

Product Quantity: 117,385 units total (33,918 units in US)

Code Information:

All Lots

Distribution Pattern:

Worldwide Distribution - USA (nationwide), Canada, and internationally.

Voluntary or Mandated:

Voluntary: Firm initiated