Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ARCHITECT HAVAB-G Calibrator Recalled by Abbott Gmbh & Co. KG Due to Abbott has identified that Calibrator lot 08219BE00 is...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Gmbh & Co. KG directly.
Affected Products
ARCHITECT HAVAB-G Calibrator, REF 6L27-01
Quantity: 83 kits
Why Was This Recalled?
Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Relative Light Units (RLUs) up to 94%. It has been confirmed that the increase in the calibrator RLU values may cause a decrease in the control values and patient results. Patient values generated using the impacted calibrator lot 08219BE00 may have changed interpretation from reactive to falsely non reactive. Results impacted may present as a (falsely) non reactive result that fall in the range between 0.50 to 0.99 S/CO.
Where Was This Sold?
This product was distributed to 22 states: AZ, CA, CO, CT, FL, KY, LA, MD, MA, MI, MN, MO, NJ, NY, OH, OR, RI, SC, TN, TX, WA, WV
About Abbott Gmbh & Co. KG
Abbott Gmbh & Co. KG has 18 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report