Reported Dec 4, 2019 · Terminated
ARCHITECT HAVAB-G Calibrator, REF 6L27-01
Abbott GmbH & Co. KG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Gmbh & Co. KG · Max-Planck-Ring 2 · Wiesbaden · N/A
Is this the product you have?
- ARCHITECT HAVAB-G Calibrator, REF 6L27-01
- Lot codes and dates
- lot number 08219BE00
- Amount recalled
- 83 kits
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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