Z-0884-05

IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074

Name: Z-0884-05 IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074
Creator: International Remote Imaging Systems Inc
Published: 2005-04-29
License: https://open.fda.gov/license/

International Remote Imaging Systems / initiated 2005-04-29 / Terminated

FDA source

International Remote Imaging Systems Inc began a recall of IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074 on 2005-04-29. The reason FDA records is "Nonconformance to performance specifications". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0884-05
Status: Terminated
Initiated: 2005-04-29
Posted: 2005-06-11
Terminated: 2012-05-07
Recalling firm: International Remote Imaging Systems
Product: IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074.
Product code: JJW Urinalysis Controls (Assayed And Unassayed)
Reason for recall: Nonconformance to performance specifications.
FDA root cause: Other
Action: Firm telephoned customers April 29, 2005 requesting return of product. All customers were contacted as of May 4, 2005.
Quantity in commerce: 107
Distribution: Nationwide.
Product codes and lots: Lot No. 103-05

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)