CLASS II Device recall · Reported 4 Dec 2019 · FDA Enforcement Report
Architect Havab-g Calibrator recalled by Abbott Gmbh & Co. KG
Abbott Gmbh & Co. KG is recalling Architect Havab-g Calibrator, distributed in 22 states. The recall was initiated on 7 Nov 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0574-2020
- FDA event ID
- 84238
- Recalling firm
- Abbott Gmbh & Co. KG, Wiesbaden
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Nov 2019
- FDA classified
- 25 Nov 2019
- Reported
- 4 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Nov 2019 | Recall initiated by company | |
| 25 Nov 2019 | Classified by FDA | +18 days |
| 4 Dec 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
ARCHITECT HAVAB-G Calibrator, REF 6L27-01
Where it was distributed
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
ArizonaCaliforniaColoradoConnecticutFloridaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNew JerseyNew YorkOhioOregonRhode IslandSouth CarolinaTennesseeTexas
Questions about this recall
Why was it 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.
Which lots are affected?
lot number 08219BE00
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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