Z-0984-2022Class III

Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA...

Name: Z-0984-2022 Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA...
Creator: Beckman Coulter, Inc.
Published: 2022-02-16
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2022-02-16 / Open, Classified

FDA source

Beckman Coulter, Inc. began a recall of Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control on 2022-02-16. FDA classified it as Class III and gives the reason as "IRISpec CA failures for glucose". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0984-2022
Classification: Class III
Status: Open, Classified
Initiated: 2022-02-16
Posted: 2022-04-21
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.
Product code: JJW Urinalysis Controls (Assayed And Unassayed)
Reason for recall: IRISpec CA failures for glucose.
FDA root cause: Under Investigation by firm
Action: The recall letter was issued via email on 2/17/2022 and by first class mail on 2/18/2022 for U.S. consignees. The letter explained the issue, the impact of the issue, and the actions to be taken by the consignee. The consignee was to update the quality control QC ranges for glucose as instructed in the letter. The ranges superseded those listed in the IFU and the assay sheet C39721AA, and the letter emphasized to use only the specifications in the notification. As an interim action, a lower limit on the glucose control range was being implemented via the notification. The letter was to serve as a labeling update for the issue until further notice. The information was to be shared with the consignee's laboratory staff and retained as part of the laboratory Quality System documentation. If the product has been forwarded to another laboratory, the consignee is to provide them a copy of the letter. The consignee was requested to respond to the notification electronically or manually within 10 days. A response form was enclosed for completion and return. Also enclosed was an addendum which provided instructions for updating the QC ranges for glucose in the analyzer. OUS consignees were notified via email and first class USPS beginning 2/16/2022.
Quantity in commerce: 12,306 kits
Distribution: Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Brazil, Canada, Curacao, Guatemala, Mexico, Philippines, Singapore, and Taiwan.
Product codes and lots: Lot #583-21 and higher, UDI 10837461002611.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0984-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0984-2022	Class III	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21

Product code JJW

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)