Recall Z-0544-2020
Abbott Gmbh & Co. KG · initiated September 16, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution
Codes / lots: List Number 03R66 03, All Serial Numbers
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.
FDA-determined cause: Device Design
Action taken
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
Details
- Recall number
- Z-0544-2020
- Initiated
- September 16, 2019
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 3,271 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…
- Recalling firm
- Abbott Gmbh & Co. KG, Wiesbaden
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0543-2020 Class II | Alinity ci Level Sensor, Bulk SolutionPotential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of… | 09/16/2019Open, Classified |
| Z-0545-2020 Class II | Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk SolutionPotential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of… | 09/16/2019Open, Classified |