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U.S. Department of Health and Human Services

Class 2 Device Recall Beckman Coulter IRISpec CA/CB/CC assayed QC material

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 Class 2 Device Recall Beckman Coulter IRISpec CA/CB/CC assayed QC materialsee related information
Date Initiated by FirmNovember 18, 2022
Date PostedJanuary 03, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0777-2023
Recall Event ID 91175
510(K)NumberK072640 
Product Classification Urinalysis controls (assayed and unassayed) - Product Code JJW
ProductBECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Code Information UDI/DI 10837461002611, Lot 565-21: 11-30-2022
FEI Number 3000203293
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
11800 Sw 147th Ave
Miami FL 33196-2500
For Additional Information ContactMs. Medha Avisetti
714-686-3113
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionThe 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 Commerce3657 units
DistributionUS and Canada, Brazil, Korea, Mexico, Puerto Rico, Taiwan
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = JJW
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