Abbott recalls five in-vitro diagnostic kits shipped to U.S. customers without U.S. approval or registration. Products intended for export only were mistakenly shipped to U.S. customers.
Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
Abbott is recalling five in-vitro diagnostic kits that were shipped to U.S. customers without proper U.S. approval or registration. These kits were intended for export only and were mistakenly sent to American customers.
The kits were intended for export only but were shipped to U.S. customers without being approved or registered according to U.S. specifications. This means they may not meet U.S. regulatory standards for use in the United States.
U.S. customers who received these specific diagnostic kits. Laboratory users and healthcare professionals are most at risk.
Check for the product names and reference numbers listed: Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe (REF 01N33-020), Abbott Vysis PTEN/CEP 10 FISH Probe Kit (REF 04N62-020), and other specific kits with their reference numbers and expiration dates.
Review the reference numbers and expiration dates listed on the kits to confirm if they are part of the recall.
These kits were intended for export only but were mistakenly shipped to U.S. customers without proper U.S. approval or registration.
Check the reference numbers and expiration dates to see if your kit is part of the recall. If it is, contact Abbott for further instructions.
The kits were not approved for U.S. use, so they may not meet U.S. regulatory standards. Do not use them for diagnostic purposes in the United States.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1189-2024 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1189-2024 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
