Iris Diagnostics: Medical Device Recall in 2012 - (Recall #: Z-2124-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.

Product Classification:

Class III

Date Initiated: July 9, 2012

Date Posted: August 8, 2012

Recall Number: Z-2124-2012

Event ID: 62555

Reason for Recall:

The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control, 101131-12, where the nitrite results read negative for the part B control, which should be positive.

Status: Terminated

Product Quantity: 862

Code Information:

Iris Diagnostics part number 800-0074, lot number 131-12.

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated