Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (
FDA device recall Z-1971-2020 · posted 2020-05-13 · Terminated
Recall details
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Reason for recall
- False positive reaction on the reagent.
- Action taken
- URGENT MEDICAL DEVICE RECALL letter was sent to the customers on 03/31/2020 via FedEx, emailed or faxed. The acknowledgement form included with the letter that is mailed, faxed, emailed, back to BD will be reconciled with the customer list.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MVU
- Quantity affected
- 1473 vials.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI and Pu
- Date initiated
- 2020-03-31
- Date posted
- 2020-05-13
- Date terminated
- 2021-04-27
- Location
- San Jose, CA
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