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U.S. Department of Health and Human Services

Class 3 Device Recall Beckman CoulterIRISpec

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  Class 3 Device Recall Beckman CoulterIRISpec see related information
Date Initiated by Firm February 16, 2022
Create Date April 21, 2022
Recall Status1 Open3, Classified
Recall Number Z-0984-2022
Recall Event ID 89655
Product Classification Urinalysis controls (assayed and unassayed) - Product Code JJW
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.
Code Information Lot #583-21 and higher, UDI 10837461002611.
Recalling Firm/
Beckman Coulter, Inc.
11800 Sw 147th Ave
Miami FL 33196-2500
For Additional Information Contact Mr. Roger Janczak
Manufacturer Reason
for Recall
IRISpec CA failures for glucose.
FDA Determined
Cause 2
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 The ranges superseded those listed in the IFU and the assay sheet C39721AA, and the letter emphasized to use only the specifications in the notification.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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.