BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.

Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.

On 10/13/2020, the firm notified it customer via telephone and sent an "URGENT MEDICAL DEVICE RECALL" Notification via email and/or FedEx to inform them that complaints have been report regarding their Low Control product which shows an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate gating with the potential for delayed patient management. Customer are instructed to: 1. Immediately review their inventory for the specific Catalog and lot numbers listed. Destroy all product subject to this recall following their institutions process for destruction. 2. Share this recall notification with all users of the product within their facility to ensure that they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the Recalling Firm contact noted on the form. Even if customer do not have any of the affected lots in their inventory, they are asked to complete the Customer Recall Response Form indicating they have zero (0) quantity and return as indicated. Return Customer Response Form via email [email protected] or fax 312-949-0371 Actions the Recalling Firm is taking: An investigation has been initiated to identify root cause and corrective actions to prevent recurrence. An questions, contact Customer/Technical Support at 877-232-8995 (prompt 2,2)