Z-0545-2020Class II

Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution

Name: Z-0545-2020 Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution
Creator: Abbott Gmbh & Co. KG
Published: 2019-09-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-09-16 / Open, Classified / root cause: design

FDA source

Abbott Gmbh & Co. KG began a recall of Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution on 2019-09-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0545-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-09-16
Posted: 2019-11-22
Recalling firm: Abbott Medical
Product: Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: 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 tag: design
FDA 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 in commerce: 1,710 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.
Product codes and lots: List Number 03R69 03 & 03R69 04, All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0545-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0543-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-12-04	2019-11-22
Z-0544-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-12-04	2019-11-22
Z-0545-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-12-04	2019-11-22

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)