ARCHITECT HAVAB-G Calibrator, REF 6L27-01 recallZ-0574-2020 · Abbott Gmbh & Co. KG · initiated Nov 7, 2019
Class II Terminated All recalls posted in November 2019
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Gmbh & Co. KG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Material/Component Contamination
What the company is doing
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.
Recall details
- Recall number
- Z-0574-2020
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 7, 2019
- Posted by the FDA
- Nov 26, 2019
- Recalling firm
- Abbott Gmbh & Co. KG
- Quantity
- 83 kits
- Product code
- LOL
- FDA submissions
- K113704
- 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
Product description
ARCHITECT HAVAB-G Calibrator, REF 6L27-01
Code information (models, lots, serial numbers)
lot number 08219BE00
Other devices under the same FDA submission
2 devices cleared under K113704 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ARCHITECT 6L27-25Abbott GmbH · KIT, SEROLOGICAL, NEGATIVE CONTROL1 recall111 reports
- ARCHITECT 6L27-01Abbott GmbH · CALIBRATOR, PRIMARY1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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