Recall Z-1196-2019— Abbott Gmbh & Co. KG
Class II · Terminated
Class II FDA medical device recall by Abbott Gmbh & Co. KG, initiated 2019-02-26, terminated 2022-09-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.. Reason: The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not deploy when a bulk solution bottle is removed from the Alinity ci series and Alinity s System..
- Recalling firm
- Abbott Gmbh & Co. KG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-02-26
- Terminated
- 2022-09-28
- Firm location
- Wiesbaden, N/A, Germany
Product description
Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
Reason for recall
The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not deploy when a bulk solution bottle is removed from the Alinity ci series and Alinity s System.
Data sourced from openFDA. This site is unofficial and independent of the FDA.