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U.S. Department of Health and Human Services

Class 3 Device Recall Software Package, iPAW 4.2 User Kit

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 Class 3 Device Recall Software Package, iPAW 4.2 User Kitsee related information
Date Initiated by FirmMay 24, 2018
Create DateOctober 31, 2018
Recall Status1 Terminated 3 on December 08, 2022
Recall NumberZ-0356-2019
Recall Event ID 80434
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
ProductSoftware Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckman Coulter Biomedical GmbH The iPAW 4.2 User Kit (PN B73489) includes the iPAW software application CD (version 4.2). This function is primarily used to copy an existing barcode ID to replace the label of an individual sample tube because the original label is deteriorated.
Code Information v4.2.1 (and 4.2, discontinued)
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact
469-961-4941
Manufacturer Reason
for Recall		Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes. When printing consecutively numbered tube labels using this optional Barcode Counter function, the system incorrectly converts numbers with consecutive multiple zeroes in the middle, potentially leading to wrong barcode IDs. The firm reports that this does not affect automated label creation or reprinting of individual labels and that no other system functions are affected.
FDA Determined
Cause 2		Software change control
ActionOn 6/4/2018 Beckman Coulter (BEC) reported that the issue will be corrected via a field modification performed by Field Service. BEC reported that they do not intend to send a customer letter for this issue.US customers can contact the Technical Support Troubleshooting Hotline at (800) 854-3633.
Quantity in Commerce14
DistributionWorldwide Distribution: US (nationwide) and countries of: Algeria, Argentina, Austria, Belgium, Brazil, Chile, China, Czech Republic, Denmark ,France, Germany, Greece ,Hong Kong, India, Ireland, Israel, Italy ,Republic of Korea, Lebanon, Lithuania ,Malaysia, Netherlands, Poland, Portugal , Qatar, Romania, Russian Federation, Saudi Arabia ,South Africa , Spain, Sweden, Taiwan, Turkey , and United Kingdom.
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.
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