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.
Reported: May 15, 2019 Initiated: August 28, 2018 #Z-1296-2019
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.
Details
- Recalling Firm
- Abbott Laboratories, Inc
- Units Affected
- 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.
- Location
- Irving, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Abbott Laboratories, Inc. Units affected: 99 modules/kits.
Why was this product recalled? ▼
There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 15, 2019. Severity: Moderate. Recall number: Z-1296-2019.
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