Abbott Recalls HAVAB-G Calibrator Due to Potential False Negative Results
Abbott is recalling 83 kits of ARCHITECT HAVAB-G Calibrator, lot 08219BE00, because increased RLU values may cause false non-reactive patient results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where the hazard is a false negative result (falsely non-reactive) that could lead to missed diagnoses, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Abbott Gmbh & Co. KG is recalling 83 kits of the ARCHITECT HAVAB-G Calibrator, reference 6L27-01, lot number 08219BE00. The recall is due to an identified increase in Relative Light Units (RLUs) of up to 94% in the affected lot.
The increase in calibrator RLU values may cause a decrease in control values and patient results. This issue may lead to patient values changing interpretation from reactive to falsely non-reactive. Impacted results may present as falsely non-reactive values in the range between 0.50 to 0.99 S/CO.
The affected product was distributed in the United States 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, and WV. Users should stop using the affected lot and contact Abbott for further instructions.
The recalled product
- Product
- ARCHITECT HAVAB-G Calibrator, REF 6L27-01
- Manufacturer
- Abbott Gmbh & Co. KG
- Affected units
- 83
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- lot number 08219BE00
Distribution
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