CLASS II Device recall · Reported 29 Apr 2020 · FDA Enforcement Report
Architect Havab G Reagent Kit recalled by Abbott Gmbh & Co. KG
Abbott Gmbh & Co. KG is recalling Architect Havab G Reagent Kit, distributed nationwide in the US. The recall was initiated on 9 Mar 2020 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-1728-2020
- FDA event ID
- 85238
- Recalling firm
- Abbott Gmbh & Co. KG, Wiesbaden, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Mar 2020
- FDA classified
- 17 Apr 2020
- Reported
- 29 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Hepatitis A
- Device type
- Test Kits & Diagnostics
Timeline
| 9 Mar 2020 | Recall initiated by company | |
| 17 Apr 2020 | Classified by FDA | +39 days |
| 29 Apr 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.
Product as listed by the FDA
ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
Where it was distributed
US nationwide including the states of AL, AR, AZ, CA, CO, CT DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM NV, NY, OH, OK, OR, PA, RH, SC, TN, TZ, UT, VA, WA, WI, WV AND PR.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIdahoIllinoisKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth Carolina
Questions about this recall
Why was it recalled?
An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.
Which lots are affected?
List Number 6L27 25. Lot No: 03429BE00, 06172BE00, 08073BE00, 10353BE00. UDI: (01)00380740011185 (17)200320(10)03429BE00, (01)00380740011185 (17)200604(10)06172BE00, (01)00380740011185 (17)200819(10)08073BE00, (01)00380740011185 (17)201023(10)10353BE00.
Where was it sold?
US nationwide including the states of AL, AR, AZ, CA, CO, CT DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM NV, NY, OH, OK, OR, PA, RH, SC, TN, TZ, UT, VA, WA, WI, WV AND PR.
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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