—#206383

Product

Access Substrate, REF 81906, For use with the Access Immunoassay Systems

FDA product code: PPM — General Purpose Reagent
Device class: Class 1
Medical specialty: Pathology
Affected lot / code info: 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¿.

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Beckman Coulter issued an "URGENT MEDICAL DEVICE RECALL" NOTICE dated 2/14/2024 to its consignees on via USPS and email. The notice explained the issue, impact, and actions to be taken. The consignees were requested to verify upon receipt that all Access substrate bottle have a label. It further directed the discard of all those without labels, Contact your Beckman Coulter representative and request a replacement order for bottles missing labels. If you have an questions regarding this notice, please contact Beckman Coulter by telephone at: call 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact your local Beckman Coulter representative. From website: http://www.beckmancoulter.com. UPDATE PER EXPANSION EMAIL DATED 10/30/2024: An Urgent Medical Device Recall letter dated 10/25/2024 was issued via email on 11/1/2024 and via postal mail on 11/7/2024 to the affected customers. The letter informed the consignee that in February 2024, the recalling firm issued an Urgent Medical Device Recall letter regarding Access Substrate bottles that may have been received without labels and that the current letter serves as an update to include additional affected lots beyond those initially listed. The customers were advised to verify upon receipt that all Access substrate bottles have a bar code label and discard all Access substrate bottles without bar code labels, according to your local regulations. Contact your Beckman Coulter representative and request a replacement order if your laboratory receives Access substrate bottles that are missing a bar code label.

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 1000 Lake Hazeltine Dr, Chaska, Minnesota 55318-1037

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-02-07
Posted by FDA: 2024-03-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206383. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.