Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 - Elecsys 2010 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
Class I - DangerousWhat Should You Do?
- Check if you have this product: none
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Roche Diagnostics Corporation
- Reason for Recall:
- A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 - Elecsys 2010 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
Product Codes/Lot Numbers:
none
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0499-2018
Related Recalls
Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reagent.
cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
Roche Diagnostics
There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
Roche Diagnostics
There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.