Z-1376-2024Class II

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

Name: Z-1376-2024 Access Substrate, REF 81906, For use with the Access Immunoassay Systems
Creator: Beckman Coulter, Inc.
Published: 2024-02-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-02-07 / Open, Classified / root cause: labeling and UDI

FDA source

Beckman Coulter, Inc. began a recall of Access Substrate, REF 81906, For use with the Access Immunoassay Systems on 2024-02-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1376-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-07
Posted: 2024-03-25
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Substrate, REF 81906, For use with the Access Immunoassay Systems
Product code: PPM General Purpose Reagent
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 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.
Product codes and lots: 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¿.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1376-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1376-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-25

Product code PPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)