Quidel Corporation: Medical Device Recall in 2013 - (Recall #: Z-0819-2013)

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:

Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.

Product Classification:

Class II

Date Initiated: December 3, 2012

Date Posted: February 20, 2013

Recall Number: Z-0819-2013

Event ID: 64017

Reason for Recall:

Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis.

Status: Terminated

Product Quantity: 13,090 kits (327,250 tests)

Code Information:

Lot # Range: 208228-214385, 707916-708108 (29 lots).

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK

Voluntary or Mandated:

Voluntary: Firm initiated