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U.S. Department of Health and Human Services

Class 2 Device Recall iChem VELOCITY Urine Chemistry Strips

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 Class 2 Device Recall iChem VELOCITY Urine Chemistry Stripssee related information
Date Initiated by FirmOctober 18, 2018
Create DateJuly 03, 2019
Recall Status1 Terminated 3 on November 10, 2020
Recall NumberZ-1937-2019
Recall Event ID 82879
510(K)NumberK101852 
Product Classification Automated urinalysis system - Product Code KQO
ProductiChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.
Code Information Lot numbers beginning with lot 7212143 except for: 7212146, 7212148, 7212160, 7212162, 7212163 and 7212164.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information ContactAruna Badiga, Ph.D.
305-380-4189
Manufacturer Reason
for Recall		Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.
FDA Determined
Cause 2		Component change control
ActionThe recalling firm issued letters dated 10/15/2018 on 10/18/2018 via email or regular mail for customers where an email was unavailable. The letter explains the issue and impact, and provides the actions the consignee is to take when using the product. The letter informed the customer they are actively working on a resolution to prevent recurrence of the issue.
Quantity in Commerce956,798/100 test strip vials
DistributionDistribution was nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, Argentina, Brazil, Chile, Colombia, Mexico, Peru, Philippines, Singapore, and 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KQO
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