Skip to content

IRISpec CA/CB/CC URINE CHEMSITRY CONTROLS

by Beckman Coulter Ireland Inc.

IRISpec CA/CB/CC URINE CHEMSITRY CONTROLS (800-7211) is a multiple urine analyte IVD (FDA Class I; FDA product code JJW, Urinalysis Controls (Assayed And Unassayed)) made by Beckman Coulter Ireland Inc., cleared under FDA 510(k) K072640 on 21 Dec 2007 and listed in FDA GUDID since 7 Sep 2016 (UDI-DI 10837461002611), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

510(k) K072640

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10837461002611 UDI-DI Date7 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK072640 Date21 Dec 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K072640 decided 21 Dec 2007 Active
  • FDA GUDID UDI-DI 10837461002611 listed 7 Sep 2016 Listed

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0093-2025 FDA Class III initiated 16 Jul 2024

    Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with iChemVELOCITY Urine Chemistry Strips (PNs 800-7204 and 800-7212) on the iChemVELOCITY Analyzer. This issue may delay the reporting of patient results, with a worst-case scenario of a delay in diagnosis or treatment of metabolic disorders, kidney function abnormalities, urinary tract infections, and liver function.

    • Ongoing Z-0777-2023 FDA Class II initiated 18 Nov 2022

    Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212

Timeline

4 dated events

  1. Cleared FDA 510(k) K072640
  2. Listed FDA GUDID 10837461002611
  3. Recall initiated FDA recalls Z-0777-2023
  4. Recall initiated FDA recalls Z-0093-2025

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
IRISpec
Generic name
Multiple urine analyte IVD, control
Model / Ref / Catalog
CA/CB/CC URINE CHEMSITRY CONTROLS, 800-7211
Primary DI / UDI-DI
10837461002611
510(k) Number
FDA product code
JJW
GMDN term
Multiple urine analyte IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple urine analyte IVD, control

Cleared under the same submission (K072640)

Similar devices in this category

Other devices filed under Multiple urine analyte IVD, control.

Other devices from Beckman Coulter Ireland Inc.

See all devices from Beckman Coulter Ireland Inc. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)