Z-0297-2021Class II

The Quidel Triage BNP Calibrators

Name: Z-0297-2021 The Quidel Triage BNP Calibrators
Creator: Medline Industries Inc
Published: 2020-10-01
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2020-10-01 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of The Quidel Triage BNP Calibrators on 2020-10-01. FDA classified it as Class II and gives the reason as "Product compromised during shipment". 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-0297-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-01
Posted: 2020-10-26
Terminated: 2021-05-03
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: The Quidel Triage BNP Calibrators
Product code: NBC Test, Natriuretic Peptide
Reason for recall: Product compromised during shipment.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 26 devices
Distribution: Domestic Distribution only to: CA, NY, TX and VA
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0297-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0297-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-04	2020-10-26

Product code NBC

K033383Class IITriage Bnp Test for the Beckman Coulter Immunoassay Systems, Model Catalog #98200Biosite Incorporated / cleared 2003-12-23

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)