Z-0179-2015Class II

Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and...

Name: Z-0179-2015 Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and...
Creator: Leica Microsystems, Inc.
Published: 2014-04-18
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2014-04-18 / Terminated / root cause: labeling and UDI

FDA source

Leica Microsystems, Inc. began a recall of Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier... on 2014-04-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0179-2015
Classification: Class II
Status: Terminated
Initiated: 2014-04-18
Posted: 2014-11-06
Terminated: 2017-08-14
Recalling firm: Leica Microsystems, Inc.
Product: 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.
Product code: NJT Immunohistochemistry Reagents And Kits
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.
Root cause tag: labeling and UDI
FDA root cause: Unknown/Undetermined by firm
Action: Leica Biosystems sent a Medical Device Recall Notification letter dated April 18, 2014, to all affected customers. The letter included instructions for customers to: 1) assess any results previously obtained by using the recalled products; 2) identify and destroy any unused or partly used recalled products or confirm that the recalled products are no longer in stock; and, 3) complete and return the attached Medical Device Recall Notification Acknowledgement Form. Customers with questions were instructed to contact Leica Microsystems by e-mail at [email protected]. For questions regarding this recall call 847-405-5413.
Quantity in commerce: 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, Italy, Pakistan, Philippines, Russia, Saudi Arabia, Spain, Turkey, and the United Kingdom.
Product codes and lots: Product Code: PA0025; Lot Numbers and Expiration Dates: 24963, Expires 17 DEC 2014; 24228, Expires 15 OCT 2014; 23882, Expires 10 SEP 2014; 23366, Expires 23 JUL 2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0179-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0179-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-12	2014-11-06

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)