Abbott Gmbh & Co. KG: Alinity ci Level Sensor, Bulk Solution

Recall number

Z-0543-2020

Recalling firm

Abbott Gmbh & Co. KG

Product

Alinity ci Level Sensor, Bulk Solution

Status

Open, Classified

Initiated

2019-09-16

Posted

not on file

Terminated

not on file

Reason

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.

Root cause

Device Design

Action

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

Quantity

8,714 units

Distribution

Nationwide distribution to AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OK, PR, SC, SD, TN, TX, UT, VA, WA, WI. International distribution to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MADAGASCAR, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UK, URUGUAY, VIETNAM.

Lot, serial or model codes

List Number 04S68-02, All Serial Numbers

510(k) numbers

not on file

PMA numbers

not on file

Product code

JJE

Firm FEI

3002809144

Firm city

Wiesbaden

Firm state

not on file

Firm country

Germany

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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