Z-0777-2023Class II

BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only

Name: Z-0777-2023 BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only
Creator: Beckman Coulter, Inc.
Published: 2022-11-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2022-11-18 / Open, Classified

FDA source

Beckman Coulter, Inc. began a recall of BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only on 2022-11-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0777-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-18
Posted: 2023-01-03
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Product code: JJW Urinalysis Controls (Assayed And Unassayed)
Reason for recall: 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
FDA root cause: Under Investigation by firm
Action: The firm issued a MEDICAL DEVICE RECALL notice to its consignees on 11/18/2022 by mail and email. The notice explained the problem and requested the following actions be taken: "If IRISpec CB controls pass (QC results are within QC acceptance criteria): Continue to process patient samples per IFU (P/N 301-7146BE) If IRISpec CB controls fail (QC results are outside QC acceptance criteria): Refer to Addendum A below for troubleshooting No retrospective review of QC or patient sample results is necessary." "Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter."
Quantity in commerce: 3657 units
Distribution: US and Canada, Brazil, Korea, Mexico, Puerto Rico, Taiwan
Product codes and lots: UDI/DI 10837461002611, Lot 565-21: 11-30-2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0777-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0777-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-11	2023-01-03

Product code JJW

K072640Class IIrispec,ca/cb/ccIris Diagnostics / cleared 2007-12-21

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)