BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Recall
- Recall Number
- Z-2237-2025
- Event Number
- 97141
- Firm
- Becton, Dickinson and Company, BD Bio Sciences
- FEI Number
- 3027394506
- Product Code
- GKZ
- Status
- Open, Classified
- Root Cause
- Labeling design
- Initiated
- July 8, 2025
- Posted
- August 1, 2025
- Address
- 155 N Mccarthy Blvd, Milpitas, CA, 95035-5102
Description
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
On July 8, 2025, BD Biosciences issued a "Urgent: Medical Device Recall Correction" via mail. BD ask consignees to take the following actions: 1. Ensure the contents of this product notification are read and understood. 2. Share and post this customer letter with the users of this application at your facility and forward to any customers to whom you may have distributed the product to ensure awareness. 3. It is recommended that this notice be posted where these products are stored. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted product, so that BD may acknowledge your receipt of this notification. 5. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program.
Worldwide - US Nationwide distribution in the states of Tennessee, New York, Massachusetts and the countries of Argentina, Belgium, Botswana, Brazil, Canada, France, Germany, Lithuania, Peru, Philippines, United Kingdom.
10 kits