ClearanceBrief
Recall Z-0297-2021 ยท NBC Test, Natriuretic Peptide

Medline Industries Inc

The Quidel Triage BNP Calibrators

DateOct 1, 2020
StatusTerminated
ReasonProduct compromised during shipment.
Root causeProcess control
ActionOn Oct 1st 2020, the firm sent a letter to its consignees with the following instructions: 1. Immediately check your stock for the affected item number and lots, listed on the attached destruction form. Quarantine all affected product. 2. Please return the completed enclosed destruction form listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. Your account will receive credit when the destruction form is received. 3. If you have transferred possession of this product to anot
Quantity26 devices
DistributionDomestic Distribution only to: CA, NY, TX and VA
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K033383TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200
Biosite Incorporated, Dec 23, 2003