Official recall record

UniCel Dxl Access Immunoassay System - Substrates

What the authority reported

Beckman Coulter is aware that customers may have received access substrate bottles without labels. Substrate labels include information the system uses to track the substrate lot number, expiration date, serial number and the number of tests remaining in an open substrate bottle. If the substrate label is missing the system will not recognize the bottle and it cannot be used. Patient results are not affected by this issue, but the reporting of results may be delayed due to the time required for a new substrate bottle to equilibrate to room temperature. Recall start date: February 12, 2024

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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