Recall Z-0749-2022— Abbott Laboratories, Inc
Class II · Ongoing
Class II FDA medical device recall by Abbott Laboratories, Inc, initiated 2022-02-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.. Reason: Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe..
- Recalling firm
- Abbott Laboratories, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-02-03
- Firm location
- Irving, TX, United States
Product description
Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.
Reason for recall
Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.
Data sourced from openFDA. This site is unofficial and independent of the FDA.