ModerateClass IITerminated

FDA Devices recall · Reported April 6, 2016

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 Pan

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on April 6, 2016. Severity: Moderate. Recall number: Z-1269-2016.

Q: Where was the recalled product distributed?

Distribution: 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..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1269-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software incorrectly allows the operator to manually edit the carbohydrate substrates when…

Recall #: Z-1269-2016
Affected scope: 2,702 units total (1,032 units in US)
Initiated: February 11, 2016

Reviewed by PlainRecalls Editorial, Product Recalls Editorial Team

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Beckman Coulter Inc. recalled MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No.… — a moderate-severity action.

MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No.… was recalled by Beckman Coulter Inc. in April 6, 2016. Reason: Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software incorrectly…. Check the official notice for the remedy. Verify recall #Z-1269-2016 with the FDA Devices before acting.

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The recall

Beckman Coulter Inc. issued this moderate-severity FDA Devices recall — Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software incorrectly….

Moderate
severity level: 3K units
affected scope: Class II
classification: April 6, 2016
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1269-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1269-2016) was formally reported on April 6, 2016, with the manufacturer initiating the action on February 11, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Beckman Coulter Inc. is listed as the recalling firm, operating out of Brea, CA. Federal records list the affected scope as 2,702 units total (1,032 units in US).

The documented reason for this recall is: 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 n… Distribution data in the federal record shows the product reached: 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, M…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

2,702 units total (1,032 units in US)

Related Recalls

6 from same agency

Product description

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.

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1269-2016
Date reported	April 6, 2016
Date initiated	February 11, 2016
Recalling firm	Beckman Coulter Inc.
Firm location	Brea, CA
Affected scope	2,702 units total (1,032 units in US)
Distribution	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, Neth…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

2,702 units total (1,032 units in US) units affected — limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) —

Large-scale (100K – 1M units) —

Massive (≥1M units) —

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1269-2016) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting — recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on April 6, 2016. Severity: Moderate. Recall number: Z-1269-2016.

Where was the recalled product distributed? ▼

Distribution: 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..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1269-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported April 6, 2016.

Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.