ARCHITECT HAVAB-G Calibrator — Class II medical device recall Z-0574-2020
Terminated recall by Abbott Gmbh & Co. KG, reported 2019-12-04, distributed in AZ, CA, CO, CT, FL, KY, LA, MA…. Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Relative Light U
| Recall number | Z-0574-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Gmbh & Co. KG, Wiesbaden, Germany |
| Recall initiated | 2019-11-07 |
| Classified | 2019-11-25 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2023-08-31 |
| Distributed | AZ, CA, CO, CT, FL, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, OR, RI, SC, TN, TX, WA, WV |
| Quantity | 83 kits |
| Lot numbers | 08219BE00 |
| Model numbers | 6L27-01 |
Product
ARCHITECT HAVAB-G Calibrator, REF 6L27-01
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0574-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.