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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80434

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 24, 2018
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Beckman Coulter Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 7

Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc. The iPAW ((intelligent Peri-Analytical Workstation) can act as: a software client for specimen tracking and workload statistics or a physical workstation for manual sorting and label printing.

Z-0353-2019
Recall number
Z-0353-2019
Initiated
May 24, 2018
Classification
Class III
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
283

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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. Sorting Drive software version 4.2 was replaced by 4.2.1 (both versions contain the same option for manual barcode printing). 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 this does not affect automated label creation or reprinting of individual labels and that no other system functions are affected.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

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. Sorting Drive software version 4.2 was replaced by 4.2.1 (both versions contain the same option for manual barcode printing). 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 this does not affect automated label creation or reprinting of individual labels and that no other system functions are affected.

Code information

v4.2.1 (and 4.2, discontinued)

Distribution pattern

Worldwide 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.

device · product 2 of 7

Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 Family of products. The system automates the process of sorting, decapping, and archiving samples. The Sorting-Drive 4.2. User Kit includes the Sorting-Drive Client software application that includes an option for manual printing of barcodes for sample tubes.

Z-0354-2019
Recall number
Z-0354-2019
Initiated
May 24, 2018
Classification
Class III
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
25

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which included 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 this does not affect automated label creation or reprinting of individual labels and that no other system functions are affected.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which included 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 this does not affect automated label creation or reprinting of individual labels and that no other system functions are affected.

Code information

v4.2.1 (and 4.2, discontinued)

Distribution pattern

Worldwide 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.

device · product 3 of 7

Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95347, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 Family of products. . The Sorting-Drive 4.2.1 User Kit includes the Sorting-Drive Client software application that includes an option for manual printing of barcodes for sample tubes; version 4.2 was replaced by version 4.2.1 (they both contain the same option for manual barcode printing). 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.

Z-0355-2019
Recall number
Z-0355-2019
Initiated
May 24, 2018
Classification
Class III
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
54

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which included the Sorting-Drive Client that is used for manual printing of barcodes; version 4.2 was replaced by 4.2.1 (they both contain the same option for manual barcode printing). 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 this does not affect automated label creation or reprinting of individual labels and that no other system functions are affected.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which included the Sorting-Drive Client that is used for manual printing of barcodes; version 4.2 was replaced by 4.2.1 (they both contain the same option for manual barcode printing). 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 this does not affect automated label creation or reprinting of individual labels and that no other system functions are affected.

Code information

v4.2.1 (and 4.2, discontinued)

Distribution pattern

Worldwide 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.

device · product 4 of 7

Software 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.

Z-0356-2019
Recall number
Z-0356-2019
Initiated
May 24, 2018
Classification
Class III
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
14

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

v4.2.1 (and 4.2, discontinued)

Distribution pattern

Worldwide 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.

device · product 5 of 7

Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95343, Manufactured by: Beckman Coulter Biomedical GmbH 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.

Z-0357-2019
Recall number
Z-0357-2019
Initiated
May 24, 2018
Classification
Class III
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
29

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

v4.2.1 (and 4.2, discontinued)

Distribution pattern

Worldwide 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.

device · product 6 of 7

Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc. The Sorting-Drive Plus Kit includes the Sorting-Drive 4.2.1 User Kit which includes the Sorting-Drive 4.2.1 Software DVD. . The Sorting-Drive software facilitates the Laboratory Information System (LIS) connection to AutoMate 2500 Family systems. .

Z-0358-2019
Recall number
Z-0358-2019
Initiated
May 24, 2018
Classification
Class III
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
495

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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. Sorting Drive software version 4.2 was replaced by 4.2.1 (both versions contain the same option for manual barcode printing). 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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

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. Sorting Drive software version 4.2 was replaced by 4.2.1 (both versions contain the same option for manual barcode printing). 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.

Code information

v4.2.1 (and 4.2, discontinued)

Distribution pattern

Worldwide 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.

device · product 7 of 7

Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software v4.2.1), Part No. A94144, Beckman Coulter, Inc. The Sorting-Drive Professional Kit (PN A94144) includes the Sorting-Drive 4.2.1 User Kit (PN B95347) which includes the Sorting-Drive 4.2.1 Software DVD (PN B95346). This software version includes an option for manual barcode printing for sample tubes. Sorting-Drive software facilitates the Laboratory Information System (LIS) connection to AutoMate 2500 Family systems.

Z-0359-2019
Recall number
Z-0359-2019
Initiated
May 24, 2018
Classification
Class III
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
58

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.Sorting Drive software version 4.2 was replaced by 4.2.1 (both versions contain the same option for manual barcode printing). 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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

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.Sorting Drive software version 4.2 was replaced by 4.2.1 (both versions contain the same option for manual barcode printing). 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.

Code information

v4.2.1 (and 4.2, discontinued)

Distribution pattern

Worldwide 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.