Recall record at a glance
| Official record | Z-1296-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Abbott Laboratories, Inc. |
| Report date | May 15, 2019 |
| Recall initiation date | Aug 28, 2018 |
| Quantity | 99 modules/kits |
| Location | Irving, TX, United States |
Official 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.
Why the product was recalled
There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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