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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73417

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
February 11, 2016
Product types
Device
Classifications
Class II
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.

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Complete imported group

Every recalled product in this event

1 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 1

MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026. Japan: 10638819 LabPro v4.11 Software Update Kit 10638820 LabPro v4.11 System Software 10805072 LabPro MBT Non-Connect Systems v4.30 10805073 LabPro MBT Connect Systems v4.30 Canada: 6000-0008 LabPro v4.41 Panel Update-06 Kit 6000-0026 LabPro Connect v4.41 Panel Update-06 Kit 10638823 LabPro v4.11 Software Update Kit 10638825 LabPro v4.11 System Software 10638824 LabPro v4.11 Software Update Kit Europe: 10638824 LabPro v4.11 Software Update Kit 10638826 LabPro v4.11 System Software USA: 10714149, LabPro v4.11 Software Update Kit 10714150 LabPro v4.11 System Software 10975000 ASM LabPro-MBT v4.40 10975001 ASM LabPro-MBT v4.40 for Connect 6000-0008 LabPro v4.41 Panel Update-06 Kit 6000-0026 LabPro Connect v4.41 Panel Update-06 Kit ROW: 6000-0008 LabPro v4.41 Panel Update-06 Kit 10638823 LabPro v4.11 Software Update Kit 10638825 LabPro v4.11 System Software 10638824 LabPro v4.11 Software Update Kit 10638826 LabPro v4.11 System Software Product Usage: LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel. LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes MicroScan ID and AST data, or other predefined parameters, against a series of established rules/alerts and notifies the user of unusual and/or critical conditions, which may warrant further analysis or actions.

Z-1269-2016
Recall number
Z-1269-2016
Initiated
February 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
2,702 units total (1,032 units in US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

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Inspect official wording and provenance

Reason for recall

Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status.

Code information

not applicable

Distribution pattern

Affected geographies: Bahamas, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, French Guiana, Germany, Ghana, Greece, Guadeloupe, Guatemala, India, Israel, Italy, Japan, Kazakhstan, Lithuania, Mexico, Morocco, Netherlands, Northern Mariana Islands, Panama, Paraguay, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Taiwan, Tunisia, Turkey, United States, Uruguay, Virgin Islands, Zimbabwe.