Access Substrate, REF 81906, For use with the Access Immunoassay Systems
Publicado el 3 de abril de 2024 · Inicio del retiro: 7 de febrero de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906) lots: 234600, 337984, 338040, 338214, 338229, 338289, 338322, 338333, 338451, 338587, and 338538. Beckman Coulter has identified that Access Substrate bottles in the identified lots were released from manufacturing without labels. Missing label may cause some patient results reporting delay but will not cause any errorreous results. However, because labs are required to have redundancy such that delay would not significantly impact clinical management and because the defect is easily recognized by the user, the probability of harm is remote.
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- Beckman Coulter, Inc.
- Distribuidor
- Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czechia, Denmark, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Maldives, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Oman, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Uzbekistan, Viet Nam, Yemen, Zambia UPDATE PER EXPANSION EMAIL DATED 10/30/2024: Distribution was made nationwide, including Guam and Puerto Rico. There was government distribution but no military distribution. The following countries received affected product identified for the recall expansion: Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Costa Rica, C¿te d'Ivoire, Croatia, Czechia, Denmark, Ecuador, Egypt, El Salvador, Estonia, Eswatini, Ethiopia, Finland, France, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Lebanon, Libya, Lithuania, Macao, Malawi, Malaysia, Maldives, Mauritius, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Province of China, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Uruguay, Uzbekistan, Viet Nam, Yemen, Zambia, Zimbabwe.
- Lote
- UDI/DI 15099590229986, Lot Numbers: 234600, 337984, 338040, 338214, 338229, 338289, 338322, 338333, 338451, 338587, 338538. UPDATED - ADDITIONAL LOT NUMBERS PER EXPANSION EMAIL DATED 10/30/2024: 234600, 234633, 234682, 234706, 234721, 234759, 234790, 234801, 234834, 234862, 337904, 337930, 337935, 337959, 337984, 338040, 338065, 338119, 338163, 338214, 338229, 338254, 338270, 338289, 338322, 338333, 338346, 338420, 338435, 33845, 33848, 338511, 338538, 338566, 338587, 338621, 338622, 338698, 338719, 338720, 338738, 338753, 338762, 338783, 338860, 338996, 339040, 339041, 339056, 339107, 339106, 339146, 439113, 439111, 439157, 439229, 439239, 439285¿.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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