Access Substrate, REF 81906, For use with the Access Immunoassay Systems
Reported: April 3, 2024 Initiated: February 7, 2024 #Z-1376-2024
Product Description
Access Substrate, REF 81906, For use with the Access Immunoassay Systems
Reason for Recall
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.
Details
- Recalling Firm
- Beckman Coulter, Inc.
- Units Affected
- 725,568 units (Updated)
- Distribution
- 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.
- Location
- Chaska, MN
Frequently Asked Questions
What product was recalled? ▼
Access Substrate, REF 81906, For use with the Access Immunoassay Systems. Recalled by Beckman Coulter, Inc.. Units affected: 725,568 units (Updated).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2024. Severity: Moderate. Recall number: Z-1376-2024.
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