ModerateClass IITerminated

FDA Devices recall · Reported July 24, 2019

Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network (E) Kaluza C Perpetual Educational License (F) Kaluza C Single User 1 Year educational License (G) Kaluza C 10 User Network Educational License (H) Kaluza C 5 User Network Educational License (I) Kaluza C Flow Cytometry Software

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on July 24, 2019. Severity: Moderate. Recall number: Z-1982-2019.

Q: Where was the recalled product distributed?

Distribution: US: CA and NY OUS: United Kingdom, Switzerland and Germany.

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

Check the product description and recall number (Z-1982-2019) 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.

Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility issue causes the software to be unusable which could result in a delay …

Recall #: Z-1982-2019
Affected scope: 41 units
Initiated: September 17, 2018

Compiled from official public sources by the editorial team. · Updated July 2026

Verify with FDA Devices →

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Beckman Coulter Inc. recalled Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the fo… - a moderate-severity action.

Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the fo… was recalled by Beckman Coulter Inc. in July 24, 2019. Reason: Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility is…. Check the official notice for the remedy. Verify recall #Z-1982-2019 with the FDA Devices before acting.

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The recall

Beckman Coulter Inc. issued this moderate-severity FDA Devices recall-Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility is….

Moderate
severity level: 41 units
affected scope: Class II
classification: July 24, 2019
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1982-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1982-2019) was formally reported on July 24, 2019, with the manufacturer initiating the action on September 17, 2018. 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 41 units.

The documented reason for this recall is: Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility issue causes the software to be unusable which could result in a delay of reporting results. Distribution data in the federal record shows the product reached: US: CA and NY OUS: United Kingdom, Switzerland and Germany. 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, 3 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 101,704 recalls in the database, 24,878 are high severity, 72,426 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

41 units

Related Recalls

3 from same agency

Product description

Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network (E) Kaluza C Perpetual Educational License (F) Kaluza C Single User 1 Year educational License (G) Kaluza C 10 User Network Educational License (H) Kaluza C 5 User Network Educational License (I) Kaluza C Flow Cytometry Software

Reason for recall

Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility issue causes the software to be unusable which could result in a delay of reporting results.

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-1982-2019
Date reported	July 24, 2019
Date initiated	September 17, 2018
Recalling firm	Beckman Coulter Inc.
Firm location	Brea, CA
Affected scope	41 units
Distribution	US: CA and NY OUS: United Kingdom, Switzerland and Germany

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

Scale of Impact

41 units 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-1982-2019) 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? ▼

Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility issue causes the software to be unusable which could result in a delay of reporting results.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on July 24, 2019. Severity: Moderate. Recall number: Z-1982-2019.

Where was the recalled product distributed? ▼

Distribution: US: CA and NY OUS: United Kingdom, Switzerland and Germany.

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

Check the product description and recall number (Z-1982-2019) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 24, 2019. 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 July 2026.