ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
Reported: April 29, 2020 Initiated: March 9, 2020 #Z-1728-2020
Product Description
ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
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.
Details
- Recalling Firm
- Abbott Gmbh & Co. KG
- Units Affected
- 7,347 kits
- Distribution
- 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.
- Location
- Wiesbaden, N/A
Frequently Asked Questions
What product was recalled? ▼
ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.. Recalled by Abbott Gmbh & Co. KG. Units affected: 7,347 kits.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on April 29, 2020. Severity: Moderate. Recall number: Z-1728-2020.
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