Beckman Coulter recalls Access Substrate (81906) lots with missing labels that could delay patient results but won't cause errors. Affected labs should check their lot numbers.
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.
Beckman Coulter is recalling Access Substrate (81906) products from specific lots due to missing labels. This may cause delays in patient results but won't lead to incorrect results. Labs using these lots should verify their product labels.
The Access Substrate bottles in the recalled lots were released without labels. Missing labels could cause delays in reporting patient results but will not cause incorrect results. Labs have redundancy systems to manage delays without significant clinical impact.
Labs using Beckman Coulter Access Substrate (81906) with the listed lot numbers are affected. Lab staff handling these products are most at risk of delayed patient results.
Check the lot number on the Access Substrate (81906) bottle. The affected lots include 234600, 337984, 338040, and other numbers listed in the recall notice. The product is used with Access Immunoassay Systems.
Verify the lot number on the Access Substrate (81906) bottle to see if it matches the recalled lots.
No, missing labels will not cause incorrect results. The recall states that patient results may be delayed but will not be erroneous.
Labs should check their lot numbers against the list provided in the recall. If affected, they may continue using the product but should monitor for delays in reporting results.
The hazard is low risk. Missing labels may delay patient results but will not cause serious injury or errors. Labs have systems to manage delays without significant clinical impact.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1376-2024 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1376-2024 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
