Leica Thyroglobulin Antibody Recalled for Reduced Performance
Leica Microsystems is recalling Thyroglobulin (1D4) antibodies because they may not function as intended up to the expiration date.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a performance defect (reduced staining intensity) rather than a direct safety risk like injury or death, fitting the Moderate criteria for low-risk issues.
Plain-English summary
Leica Microsystems, Inc. is recalling 180 units of Thyroglobulin (1D4) monoclonal antibody. This product is a reagent for in vitro diagnostic use, intended for the qualitative identification of thyroglobulin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated Bond system.
The recall was initiated because the product does not function as intended up to the expiry date on the product labeling. This issue was detected through an ongoing stability program, which identified a link between the age of the product and staining intensity.
The affected lots are 24963, 24228, 23882, and 23366. The product was distributed worldwide, including in the United States and various international locations. Users should stop using the product and contact the manufacturer for further instructions.
The recalled product
- 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.…
- Manufacturer
- Leica Microsystems, Inc.
- Hazard
- Affected units
- 180
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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
Distribution
Related recalls
Same manufacturer · Leica Microsystems, Inc.
See all →- HighSurgical Microscope Power Supply May Overheat and Cause Unexpected Shutdown
FDA (Devices) · 2022-12-21
- HighSurgical microscope power supply may overheat and cause unexpected shutdown
FDA (Devices) · 2022-12-21
- HighLeica Provido surgical microscope models at risk of unexpected power shutdown
FDA (Devices) · 2022-12-21
- HighLeica Surgical Operating Microscopes ARveo 8 recalled for illumination accuracy issue
FDA (Devices) · 2022-10-05
- HighLeica Surgical Operating Microscopes recalled for illumination adjustment defect
FDA (Devices) · 2022-10-05
Same hazard · performance defect
See all →- SevereBD Alaris Pump Infusion Sets Recalled for Performance Data Discrepancies
FDA (Devices) · 2026-09-23
- ModerateBD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production
FDA (Devices) · 2026-05-06
- ModerateBD GasPak EZ CO2 Pouch System gas generating sachets underperforming
FDA (Devices) · 2026-05-06
- ModeratePhilips C5-2 Ultrasound Transducers Refurbished Beyond Useful Life
FDA (Devices) · 2025-07-09
- ModerateThermo SCIENTIFIC Sensititre Mueller-Hinton Broth diagnostic device recalled
FDA (Devices) · 2025-06-18
Similar recalls
- ModerateLeica CD15 Antibody Recalled for Reduced Function Before Expiration
FDA (Devices) · 2014-06-11
- ModerateLeica CD15 Antibody Recalled for Decreasing Staining Intensity
FDA (Devices) · 2015-04-01
- ModerateLeica Microsystems Recalls Unstable CD10 Monoclonal Antibody Diagnostic Reagents
FDA (Devices) · 2015-12-02
- ModerateLeica Calretinin Antibody Recalled for Reduced Staining Performance
FDA (Devices) · 2016-06-01
- ModerateLeica TdT Staining Reagent Recalled for Stability Issues
FDA (Devices) · 2012-12-19
- ModerateLeica Biosystems Recalls Podoplanin Antibody Due to Temperature Excursion
FDA (Devices) · 2017-09-20