FDA Device recall Z-0574-2020
ARCHITECT HAVAB-G Calibrator, REF 6L27-01
- FDA Device
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of ARCHITECT HAVAB-G Calibrator, REF 6L27-01 by Abbott And Kg, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0574-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-07 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott And Kg |
| Distribution | AZ, CA, CO, CT, FL, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, OR, RI, SC, TN, TX, WA, WV |
Product
ARCHITECT HAVAB-G Calibrator, REF 6L27-01
Reason
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.
Identifiers
| code_info | lot number 08219BE00 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0574-2020%22
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