Alere San Diego, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2270-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.

Product Classification:

Class III

Date Initiated: June 22, 2016

Date Posted: August 3, 2016

Recall Number: Z-2270-2016

Event ID: 74505

Reason for Recall:

The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.

Status: Terminated

Product Quantity: N/A

Code Information:

all lots are affected

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated