Recall Z-1296-2019— Abbott Laboratories, Inc
Class II · Terminated
Class II FDA medical device recall by Abbott Laboratories, Inc, initiated 2018-08-28, terminated 2020-09-23. It names one FDA 510(k) clearance: K980367. Product: 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.. Reason: There is a potential to generate falsely elevated serum or plasma chloride results when using the product..
- Recalling firm
- Abbott Laboratories, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-28
- Terminated
- 2020-09-23
- Firm location
- Irving, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.