Bio-Rad Laboratories, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1537-2014)

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:

Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and abnormal hemoglobin.

Product Classification:

Class II

Date Initiated: April 8, 2014

Date Posted: May 14, 2014

Recall Number: Z-1537-2014

Event ID: 68016

Reason for Recall:

There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used.

Status: Terminated

Product Quantity: 457 kits

Code Information:

Catalog number: 270-2103 (250 tests; Reorder pack lot number: 64005302, Expiration: 4/2015; Catalog number: 270-2154 (500 tests) Reorder pack lot number: 64005207, Expiration: 6/2015; 64004750, Expiration: 11/2015

Distribution Pattern:

Worldwide Distrubution ; USA INCLUDING CA, NY, GA, NC, AL, NJ, CT, WA, NY, LA, Il, MA and Internationally to China, Australia, Canada, France, Great Britain, Hong Kong, Thailand, Singapore,and Brazil.

Voluntary or Mandated:

Voluntary: Firm initiated