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Spot-Light Tissue Pretreatment Kit
- Starting date:
- November 10, 2016
- Posting date:
- December 13, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-61388
Reason
Thermo Fisher Scientific received a customer complaint for Spotlight Tissue Pre-treatment Kit (Lot# 1714439A) which caused sample over-pepsinization. The investigation revealed four lots of Spotlight Tissue Pre-treatment kit contained an incorrectly formulated kit component (reagent 2). Data entry errors made during the reagent 2 manufacturing process caused an incorrect amount of pepsin to be added to the component.
Affected products
Spot-Light Tissue Pretreatment Kit
Lot or serial number
- 1667961A
- 1713166A
- 1714439A
- 1763308A
Model or catalog number
- 10190302000048
Companies
- Manufacturer
-
Life Technologies Corp. (Invitrogen)
7335 Executive Way
Frederick
21704
Maryland
UNITED STATES