Abbott ARCHITECT cSystems ICT Module Recall for False Chloride Results
Abbott is recalling ARCHITECT cSystems ICT Modules due to a potential for falsely elevated serum or plasma chloride results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when the defect involves significant diagnostic errors that could impact patient care.
Plain-English summary
Abbott Laboratories, Inc. is recalling the ARCHITECT cSystems ICT Module, REF 09D28-03. This medical device is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine. The recall involves 99 modules/kits from Lot No. 180326, with an expiration date of 12/26/2018.
The recall is being conducted because there is a potential to generate falsely elevated serum or plasma chloride results when using the product. The agency has classified this as a Class II recall.
The affected products were distributed worldwide, including nationwide in the United States in the states of AR, CA, CT, FL, IA, IN, LA, MA, MD, MS, NJ, NY, PA, SC, TX, VT, WA, and WV. Foreign distribution was made to Australia, China, Hong Kong, and New Zealand. Government distribution occurred, but no military distribution was reported. Users should stop using the affected modules and contact Abbott Laboratories for further instructions.
The recalled product
- 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.
- Manufacturer
- Abbott Laboratories, Inc
- Affected units
- 99
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot No. 180326
- Exp. 12/26/2018
Distribution
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