Thyroglobulin — Class II medical device recall Z-0179-2015
Terminated recall by Leica Microsystems, Inc., reported 2014-11-12, distributed in AR, AZ, CA, CO, CT, DC, FL, GA…. Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry date on the pr
| Recall number | Z-0179-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leica Microsystems, Inc., Buffalo Grove, IL, United States |
| Recall initiated | 2014-04-18 |
| Classified | 2014-11-06 |
| Reported by FDA | 2014-11-12 |
| Terminated | 2017-08-14 |
| Distributed | AR, AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI |
| Countries outside the US | BE, BG, ES, FR, GB, IT, PH, PK, RU, SA, TR |
| Quantity | 180 units |
| Reason classes | specification failure |
| Lot numbers | 23366, 23882, 24228, 24963 |
| Expiration dates | 2014-07-23, 2014-09-10, 2014-10-15, 2014-12-17 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0179-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.