Recalls / —

—#183235

Product

Control, Calibrator Verified, Triage BNP, Model ALR88755

FDA product code

JJY — Multi-Analyte Controls, All Kinds (Assayed)

Device class

Class 1

Medical specialty

Clinical Chemistry

510(k) numbers

K072892

Affected lot / code info

Lot Number and/or Serial Number: 30718, 407522, 420694, 422646, 430000, 422647N, 422648N, 428255N,428256N, 441421N, 441422N, 441423N

Why it was recalled

Product was shipped with refrigeration (ice) instead of frozen (dry ice).

Root cause (FDA determination)

Process control

Action the firm took

Medline Industries sent formal letters with response forms to affected consignees via 1st class mail on August 3, 2020. Customers were asked to initiate sub-recalls where appropriate. Consignees were provided with a destruction form to return via fax or email. Each destruction form received with be recorded and Medline Industries, Inc. will send subsequent letters to consignees that have not provided a response to the recall notification in the allotted time. Consignees are asked to confirm the destruction of any affected product on hand.

Recalling firm

Firm

Medline Industries Inc

Address

Three Lakes Drive, Northfield, Illinois 60093

Distribution

Distribution pattern

Distribution in US - AR, AZ, CO, FL, MD, MS, MI, NC, NM, NY, OK, PA, RI, TX

Timeline

Recall initiated

2020-07-28

Terminated

2023-02-13

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #183235. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.