BioMerieux SA: Medical Device Recall in 2014 - (Recall #: Z-2152-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.

Product Classification:

Class II

Date Initiated: October 14, 2013

Date Posted: August 13, 2014

Recall Number: Z-2152-2014

Event ID: 68749

Reason for Recall:

Product is not approved or authorized for distribution in the US.

Status: Terminated

Product Quantity: 1902

Code Information:

Lot 1001904130

Distribution Pattern:

FL, LA, MI, MS, NV, OH, OK, TN, TX

Voluntary or Mandated:

Voluntary: Firm initiated