Leica CD15 Antibody Recalled for Reduced Function Before Expiration
Leica Microsystems is recalling 145 units of CD15 antibody that may not function as intended before the expiration date due to age-related staining issues.
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, and the hazard involves a functional defect (reduced staining intensity) rather than a direct physical injury or contamination, fitting the Moderate severity criteria for low-risk issues.
Plain-English summary
Leica Microsystems, Inc. is recalling 145 units of Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15). The product is a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative, intended for in vitro diagnostic use. The recall involves specific lot numbers 6017936 (Expires 2014-08) and 6015073 (Expires 2014-03).
The recall is being conducted because the product does not function as intended up to the expiry date on the product labeling. There is a link between the age of the product and staining intensity, which may affect diagnostic results.
The product was distributed worldwide, including in the US states of CA, CT, FL, IL, MO, MS, NC, NY, and PA, as well as in Argentina, Australia, Brazil, Colombia, Italy, Malaysia, New Zealand, Nigeria, Poland, Romania, Russia, Saudi Arabia, Serbia, South Africa, Sweden, Taiwan, Tunisia, Turkey, and the United Kingdom. Users should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use.
- Manufacturer
- Leica Microsystems, Inc.
- Hazard
- Affected units
- 145
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 (5)
- Product Code: NCL-L-CD15
- Lot Numbers and Expiration Dates: 6017936
- Expires 2014-08
- 6015073
- Expires 2014-03
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 recalled for illumination adjustment defect
FDA (Devices) · 2022-10-05
- HighLeica M530 Surgical Microscopes recalled for illumination adjustment defect
FDA (Devices) · 2022-10-05
Same hazard · functional defect
See all →- ModerateSunMed Tracheal Tube Recalled Due to Suction Catheter Passage Issues
FDA (Devices) · 2026-09-23
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
Similar recalls
- ModerateLeica CD15 Antibody Recalled for Decreasing Staining Intensity
FDA (Devices) · 2015-04-01
- ModerateLeica Monoclonal Antibody Recalled for Reduced Functionality
FDA (Devices) · 2014-06-11
- ModerateLeica Microsystems Recalls Unstable CD10 Monoclonal Antibody Diagnostic Reagents
FDA (Devices) · 2015-12-02
- ModerateLeica Microsystems Recalls Unstable CDX2 Antibody Lots
FDA (Devices) · 2016-06-08
- ModerateLeica Novocastr Antibody Recalled for Stability Issues
FDA (Devices) · 2016-06-08
- ModerateLeica Thyroglobulin Antibody Recalled for Reduced Performance
FDA (Devices) · 2014-11-12