Recall Z-0074-2020

Reason for recall

Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

FDA-determined cause: Under Investigation by firm

Action taken

On 08/19/19, the recalling firm started calling and distributing Urgent Medical Device Recall notices to customers. Laboratory managers were asked to do the following: 1) Run the Abort Count Quantification Protocol. 2) Record the percentage of aborted events on the attached Customer Response Form and submit via fax, email, or online to the recalling firm regardless of the result. 3) For percent aborted events less-than 1.0 percent: your instrument is performing as expected and no further action is required once the percent aborted events has been provided to via Customer Response Form. 4) For percent aborted events greater-than-or-equal-to 1.0 percent: suspend all patient testing. A Technical Representative will contact you within 24 hours (Mon-Fri) of receiving the data (response form) to schedule a service visit. 5) Refer to the Frequently Asked Questions document for more information. Recalling firm is investigating the root cause and to identify actions to prevent recurrence. Customers with additional questions are encouraged to call: Customer/Technical Support at 844-918-0554.