Recalls / —

—#184036

Product

The Quidel Triage BNP Calibrators

FDA product code

NBC — Test, Natriuretic Peptide

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K033383

Affected lot / code info

Model Number: ALR98202  Expiration date:  Lot 832243, exp date 12/31/19 Lot 832570, exp date 03/31/20 Lot 921292, exp date 08/31/20 Lot 921565, exp date 12/31/20 Lot 921836, exp date 02/28/21  Lot 922069, exp date 03/31/21

Why it was recalled

Product compromised during shipment.

Root cause (FDA determination)

Process control

Action the firm took

On 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 another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication.

Recalling firm

Firm

Medline Industries Inc

Address

3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern

Domestic Distribution only to: CA, NY, TX and VA

Timeline

Recall initiated

2020-10-01

Terminated

2021-05-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #184036. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.