Alinity m Integrated Reaction Units (IRU)
Reported: March 9, 2022 Initiated: February 11, 2022 #Z-0710-2022
Product Description
Alinity m Integrated Reaction Units (IRU)
Reason for Recall
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
Details
- Recalling Firm
- Abbott Molecular, Inc.
- Units Affected
- 3063 kits
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MI, MO, NC, NJ, NY, OK, RI, SD, TX, WA, and WI.
- Location
- Des Plaines, IL
Frequently Asked Questions
What product was recalled? ▼
Alinity m Integrated Reaction Units (IRU). Recalled by Abbott Molecular, Inc.. Units affected: 3063 kits.
Why was this product recalled? ▼
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 9, 2022. Severity: Moderate. Recall number: Z-0710-2022.
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