ModerateClass IITerminated

FDA Devices recall · Reported March 19, 2014

CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on March 19, 2014. Severity: Moderate. Recall number: Z-1195-2014.

Q: Where was the recalled product distributed?

Distribution: Worldwide Distribution - USA Nationwide.

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

Check the product description and recall number (Z-1195-2014) 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.

Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿.

Recall #: Z-1195-2014
Affected scope: 19 units
Initiated: January 8, 2014

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

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Veridex, LLC recalled CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER … - a moderate-severity action.

CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER … was recalled by Veridex, LLC in March 19, 2014. Reason: Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿.. Check the official notice for the remedy. Verify recall #Z-1195-2014 with the FDA Devices before acting.

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The recall

Veridex, LLC issued this moderate-severity FDA Devices recall-Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿..

Moderate
severity level: 19 units
affected scope: Class II
classification: March 19, 2014
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1195-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1195-2014) was formally reported on March 19, 2014, with the manufacturer initiating the action on January 8, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Veridex, LLC is listed as the recalling firm, operating out of Raritan, NJ. Federal records list the affected scope as 19 units.

The documented reason for this recall is: Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA Nationwide. 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

19 units

Related Recalls

3 from same agency

Product description

CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.

Reason for recall

Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿.

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-1195-2014
Date reported	March 19, 2014
Date initiated	January 8, 2014
Recalling firm	Veridex, LLC
Firm location	Raritan, NJ
Affected scope	19 units
Distribution	Worldwide Distribution - USA Nationwide

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

Scale of Impact

19 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-1195-2014) 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? ▼

Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on March 19, 2014. Severity: Moderate. Recall number: Z-1195-2014.

Where was the recalled product distributed? ▼

Distribution: Worldwide Distribution - USA Nationwide.

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

Check the product description and recall number (Z-1195-2014) 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 March 19, 2014. 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.