Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution
Brand
Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany
Lot Codes / Batch Numbers
List Number 03R69 03 & 03R69 04, All Serial Numbers
Products Sold
List Number 03R69 03 & 03R69 04, All Serial Numbers
Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany is recalling Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution due to Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution lev. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.
Recommended Action
Per FDA guidance
Abbott GmbH & Co. KG notified customers on about 09/16/2019, via "Product Correction Urgent Immediate Action Required" letter. Customers were informed that the development of environmental stress on the bulk solution level sensor can cause cracks. Cracks can allow air to enter the fluid line, which may result either a failure to dispense or an incomplete dispense of the bulk solution on Alinity i and Alinity c. Instructions included that if using Alinity i, and you receive one of the following message codes: 1043, 1044, 1072, 1402, 1403. Refer to Appendix B in the letter. If using Alinity c, and you receive one of the following message codes: 3687, 3689. Refer to Appendix B in the letter. For both Alinity i and c, and those "if" scenarios occur, then discontinue reporting results until troubleshooting is complete and inspect the Alinity ciseries bulk solution level sensors per the instructions in Appendix A in the letter. If a bulk solution level sensor is found to be cracked: Replace the part before running the system using the replacement instructions found in the Alinity ciseries Operations Manual and Abbott recommends following your laboratory procedure to review results produced since your last successful Quality Control (QC). Last, if the level sensor is not cracked, refer to the Alinity ciseries Operations Manual to troubleshoot for the specific message code. To assist in the detection of a cracked bulk solution level sensor, Abbott recommends running Quality Control (QC) immediately before performing weekly maintenance. If your laboratory had previously identified cracks on the bulk solution level sensor before receipt of this communication, and there are messages associated with patient results in the Alinity ciseries System Logs during the same time period, Abbott recommends following your laboratory procedure to review results produced from the replacement of the bulk solution level sensor to the previous successful Quality Co
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026