Z-3054-2020Class II

Control, Calibrator Verified, Triage BNP, Model ALR88755

Name: Z-3054-2020 Control, Calibrator Verified, Triage BNP, Model ALR88755
Creator: Medline Industries Inc
Published: 2020-07-28
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2020-07-28 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of Control, Calibrator Verified, Triage BNP, Model ALR88755 on 2020-07-28. FDA classified it as Class II and gives the reason as "Product was shipped with refrigeration (ice) instead of frozen (dry ice)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3054-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-28
Posted: 2020-09-30
Terminated: 2023-02-13
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Control, Calibrator Verified, Triage BNP, Model ALR88755
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: Product was shipped with refrigeration (ice) instead of frozen (dry ice).
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 118 units
Distribution: Distribution in US - AR, AZ, CO, FL, MD, MS, MI, NC, NM, NY, OK, PA, RI, TX
Product codes and lots: Lot Number and/or Serial Number: 30718, 407522, 420694, 422646, 430000, 422647N, 422648N, 428255N,428256N, 441421N, 441422N, 441423N

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3054-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3054-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30

Product code JJY

K072892Class ITriage Total Controls 5, Triage Total Calibration Verification 5Biosite Incorporated / cleared 2007-12-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)