Abbott recalls two in-vitro diagnostic kits shipped to U.S. customers without U.S. approval. Products intended for export were mistakenly sent to U.S. markets, posing no immediate safety risk but requiring return.
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 two in-vitro diagnostic kits that were shipped to U.S. customers without proper U.S. approval. These kits were intended for export only and were mistakenly sent to the U.S. market. The recall does not pose a safety risk but requires customers to return the products.
The kits were intended for export only and 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, but the recall does not indicate a safety hazard like injury or malfunction.
U.S. customers who purchased the Abbott Vysis MDM2 / CEP 12 FISH Probe Kit or Abbott Vysis LSI D13S319 kits. Laboratory users and healthcare professionals are most at risk as they may use the kits without proper regulatory approval.
Check for the product names: Abbott Vysis MDM2 / CEP 12 FISH Probe Kit (REF 01N15-010) or Abbott Vysis LSI D13S319 (REF 01N34-020). Look for the lot numbers and expiration dates listed in the recall notice.
Contact Abbott Molecular, Inc. to return the kits using the provided lot numbers and expiration dates.
The recall states the kits were intended for export only and not approved for U.S. use, but there is no indication of safety hazards. They should be returned as per the recall instructions.
Return the kits to Abbott Molecular, Inc. using the lot numbers and expiration dates listed in the recall notice.
The recall does not mention any safety risks, so there is no immediate danger of injury or harm.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1188-2024 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1188-2024 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.
