Z-1535-2020Class II

iChemVELOCITY Strips, Catalog 800-7212

Name: Z-1535-2020 iChemVELOCITY Strips, Catalog 800-7212
Creator: Beckman Coulter, Inc.
Published: 2020-02-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-02-17 / Terminated

FDA source

Beckman Coulter, Inc. began a recall of iChemVELOCITY Strips, Catalog 800-7212 on 2020-02-17. FDA classified it as Class II and gives the reason as "The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1535-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-17
Posted: 2020-03-20
Terminated: 2021-05-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: iChemVELOCITY Strips, Catalog 800-7212
Product code: KQO Automated Urinalysis System
Reason for recall: The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Recall letter will be sent during the week of 02/17/2020 to the affected customers via email and mail. Customers are advised to discard the affected product and order a replacement from BEC.
Quantity in commerce: 10822 vials
Distribution: Distribution in US including Puerto Rico, Canada, and Taiwan
Product codes and lots: Catalog 800-7212, UDI 10837461002628; Lot 7212269M

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1535-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1535-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-20

Product code KQO

K101852Class IChem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I / cleared 2011-03-23

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)