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Terminated

The Quidel Triage BNP Calibrators

FDA Recall Z-0297-2021 · Posted None

Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeNBC
Date Initiated2020-10-01
Date Terminated2021-05-03
Product Quantity26 devices

Reason for Recall

Product compromised during shipment.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033383TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200Biosite Incorporated · 2003-12-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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