Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany ARCHITECT HAVAB-G Calibrator, REF 6L27-01 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARCHITECT HAVAB-G Calibrator, REF 6L27-01
Brand
Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany
Lot Codes / Batch Numbers
lot number 08219BE00
Products Sold
lot number 08219BE00
Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany is recalling ARCHITECT HAVAB-G Calibrator, REF 6L27-01 due to Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Relative Light Units (RLUs) up to 94%. It has been confi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm initiated the recall by letter on 11/07/2019. The letter explained the issue and requested that the consignee discontinue use of the product and destroy it. The firm is providing replacement material.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, CT, FL, IN, KY, LA, MD, MA, MI, MN, MO, NJ, NY, OH, OR, RI, SC, TN, TX, WA, WV
Page updated: Jan 10, 2026