Recall Z-1296-2019 ยท CGZ Electrode, Ion-Specific, Chloride
Abbott Laboratories, Inc
Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.
| Date | Aug 28, 2018 |
| Status | Terminated |
| Reason | There is a potential to generate falsely elevated serum or plasma chloride results when using the product. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued letters dated 8/28/2018 via overnight mail. The letter explained the issue, patient impact, and instructed the consignee to immediately discontinue use of the product and destroy any remaining inventory of the impacted lot number. The letter was to be reviewed with the Medical Director and laboratory protocol should be followed regarding the need to review previously-reported patient results. A Customer Reply Form was enclosed for the U.S. consignees to indicate the consignee understood and completed the necessary actions to be taken. For questions regarding this |
| Quantity | 99 modules/kits |
| Distribution | Worldwide Distribution - US Nationwide in the states of AR, CA, CT, FL, IA, IN, LA, MA, MD, MS, NJ, NY, PA, SC, TX, VT, WA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Australia, China, Hong Kong, and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |