ModerateClass IITerminated

FDA Devices recall · Reported November 12, 2014

Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL. This reagent is for in vitro diagnostic use. Thyroglobulin (1D4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of thyroglobulin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on November 12, 2014. Severity: Moderate. Recall number: Z-0179-2015.

Q: Where was the recalled product distributed?

Distribution: Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MT, MY, NC, NH, NJ, NY, OH, ON, OR, PA, TN, TX, UT, VA, WA, WI and the District of Columbia, Internationally to Belgium, Bulgaria, France, Italy, Pakistan, Philippines, Russia, Saudi Arabia, Spain, Turkey, and the United Kingdom..

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.

Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry date on the product labelling. This was detected through an on-going stability prog…

Recall #: Z-0179-2015
Affected scope: 180 units
Initiated: April 18, 2014

Compiled from official public sources by the publisher. · Updated September 2026

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Leica Microsystems, Inc. recalled Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue cultur… - a moderate-severity action.

Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue cultur… was recalled by Leica Microsystems, Inc. in November 12, 2014. Reason: Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry date on the p…. Check the official notice for the remedy. Verify recall #Z-0179-2015 with the FDA Devices before acting.

The recall

Leica Microsystems, Inc. issued this moderate-severity FDA Devices recall-Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry date on the p….

Moderate
severity level: 180 units
affected scope: Class II
classification: November 12, 2014
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0179-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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 agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL. This reagent is for in vitro diagnostic use. Thyroglobulin (1D4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of thyroglobulin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated Bond system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Reason for recall

Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry date on the product labelling. This was detected through an on-going stability program. There is a link between the age of the product and staining intensity.

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-0179-2015
Date reported	November 12, 2014
Date initiated	April 18, 2014
Recalling firm	Leica Microsystems, Inc.
Firm location	Buffalo Grove, IL
Affected scope	180 units
Distribution	Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MT, MY, NC, NH, NJ, NY, OH, ON, OR, PA, TN, TX, UT, VA, WA, WI and the District of Columbia, Internationally to Belgium, Bulgaria, France,…

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

Scale of Impact

180 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-0179-2015) 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 November 12, 2014. Severity: Moderate. Recall number: Z-0179-2015.

Where was the recalled product distributed? ▼

Distribution: Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MT, MY, NC, NH, NJ, NY, OH, ON, OR, PA, TN, TX, UT, VA, WA, WI and the District of Columbia, Internationally to Belgium, Bulgaria, France, Italy, Pakistan, Philippines, Russia, Saudi Arabia, Spain, Turkey, and the United Kingdom..

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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported November 12, 2014. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026