Z-2124-2012Class III

IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074

Name: Z-2124-2012 IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074
Creator: Iris Diagnostics
Published: 2012-07-09
License: https://open.fda.gov/license/

International Remote Imaging Systems / initiated 2012-07-09 / Terminated / root cause: manufacturing process

FDA source

Iris Diagnostics began a recall of 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... on 2012-07-09. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2124-2012
Classification: Class III
Status: Terminated
Initiated: 2012-07-09
Posted: 2012-08-01
Terminated: 2014-01-27
Recalling firm: International Remote Imaging Systems
Product: 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 code: JJW Urinalysis Controls (Assayed And Unassayed)
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm initiated the recall on 07/09/12 by sending out a Medical Device Recall notification to customers via e-mail. The recall notification identified the affected product, reason for recall, and instructions on the recall. Customers were to confirm how many sets of unopened or partially opened IRISpec CA/CB that was in their inventory, dispose of the affected product, and provide written confirmation of the product's disposition. The letter also stated that Iris Diagnostics would replace any unused inventory that was returned at no charge to the customer. Contact information for the recall was also provided. The communications also included a fax response sheet for return/replacement.
Quantity in commerce: 862
Distribution: Nationwide Distribution
Product codes and lots: Iris Diagnostics part number 800-0074, lot number 131-12.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2124-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2124-2012	Class III	Terminated	Voluntary: Firm initiated	2012-08-08	2012-08-01

Product code JJW

K945913Class IIrispec Urine Chemistry Control Part a and BInternational Remote Imaging Systems / cleared 1995-04-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)