Z-1937-2019Class II

iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is...

Name: Z-1937-2019 iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is...
Creator: Beckman Coulter Inc.
Published: 2018-10-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-10-18 / Terminated

FDA source

Beckman Coulter Inc. began a recall of iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland... on 2018-10-18. FDA classified it as Class II and gives the reason as "Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1937-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-18
Posted: 2019-07-03
Terminated: 2020-11-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.
Product code: KQO Automated Urinalysis System
Reason for recall: Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.
FDA root cause: Component change control
Action: The recalling firm issued letters dated 10/15/2018 on 10/18/2018 via email or regular mail for customers where an email was unavailable. The letter explains the issue and impact, and provides the actions the consignee is to take when using the product. The letter informed the customer they are actively working on a resolution to prevent recurrence of the issue.
Quantity in commerce: 956,798/100 test strip vials
Distribution: Distribution was nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, Argentina, Brazil, Chile, Colombia, Mexico, Peru, Philippines, Singapore, and Taiwan.
Product codes and lots: Lot numbers beginning with lot 7212143 except for: 7212146, 7212148, 7212160, 7212162, 7212163 and 7212164.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1937-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1937-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-03

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)