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Terminated

Control, Calibrator Verified, Triage BNP, Model ALR88755

FDA Recall Z-3054-2020 · Posted None

Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeJJY
Date Initiated2020-07-28
Date Terminated2023-02-13
Product Quantity118 units

Reason for Recall

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

Firm Action

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.

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072892TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5Biosite Incorporated · 2007-12-07

Official Source

View FDA Recall →

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

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