Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Access Substrate, REF 81906, For use with the Access Immunoassay Systems
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.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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¿.
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
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.
Recall record
- Recalling firm
- Beckman Coulter, Inc.
- Product type
- Devices
- Recall number
- Z-1376-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Origin
- Chaska, MN
- Recall initiated
- 2024-02-07
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1376-2024 · Source: openFDA enforcement.