Alere San Diego, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1178-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum.

Product Classification:

Class II

Date Initiated: March 6, 2013

Date Posted: May 1, 2013

Recall Number: Z-1178-2013

Event ID: 64701

Reason for Recall:

The Alere Cholestech LDX¿ hsCRP cassette (PN 12-807) may have increased imprecision relative to the performance data in the package insert, which may cause differences in quantitative results for hsCRP compared to a reference method or repeat testing on the same patient sample.

Status: Terminated

Product Quantity: 2333 kits

Code Information:

Model Number 12-807. ¿ Lot/Unit Codes: 274632, 281847 ¿ Expiration date, or Expected shelf life: 5/5/13, 6/30/13

Distribution Pattern:

USA Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated