# FDA recall Z-0574-2020

> **Abbott Gmbh & Co. KG** · Class II · device recall initiated 2019-11-07.

## 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.

## Distribution

US in the states of:  AZ, CA, CO, CT, FL, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, OR, RI, SC, TN, TX, WA, WV

## Key facts

- **Recall number:** Z-0574-2020
- **Recalling firm:** Abbott Gmbh & Co. KG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-07
- **Report date:** 2019-12-04
- **Termination date:** 2023-08-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wiesbaden, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0574-2020

## Citation

> AI Analytics. FDA recall Z-0574-2020. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0574-2020. Source: US FDA. Licensed CC0.

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