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U.S. Department of Health and Human Services

Class 3 Device Recall IRISpec CA/CB/CC Urine Chemistry Controls

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 Class 3 Device Recall IRISpec CA/CB/CC Urine Chemistry Controlssee related information
Date Initiated by FirmJuly 16, 2024
Date PostedOctober 16, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0093-2025
Recall Event ID 95159
510(K)NumberK072640 
Product Classification Urinalysis controls (assayed and unassayed) - Product Code JJW
ProductBeckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
Code Information UDI/DI 10837461002611, Lot Numbers: 432-24 and higher
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
11800 Sw 147th Ave
Miami FL 33196-2500
For Additional Information ContactJennifer Chau
916-857-6006
Manufacturer Reason
for Recall		Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with iChemVELOCITY Urine Chemistry Strips (PNs 800-7204 and 800-7212) on the iChemVELOCITY Analyzer. This issue may delay the reporting of patient results, with a worst-case scenario of a delay in diagnosis or treatment of metabolic disorders, kidney function abnormalities, urinary tract infections, and liver function.
FDA Determined
Cause 2		Under Investigation by firm
ActionBeckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees beginning on 07/15/2024 by letter delivered by either USPS first class mail or email. The notice explained the issue, potential impact, and provided updated QC ranges for Glucose in the Analyzer. The information is to be shared with all affected parties. For questions: please contact Customer Support Center or your local representative; From our website: http://www.beckmancoulter.com By phone: Call 800-526-7694 in the United States and Canada. o Outside the United States and Canada, contact your local Beckman Coulter representative.
Quantity in Commerce5589 units
Distributionworldwide
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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