FDA Medical Device Recalls (openFDA)
Medline Industries Inc: The Quidel Triage BNP Calibrators
- Recall number
- Z-0297-2021
- Recalling firm
- Medline Industries Inc
- Product
- The Quidel Triage BNP Calibrators
- Status
- Terminated
- Initiated
- 2020-10-01
- Posted
- not on file
- Terminated
- 2021-05-03
- Reason
- Product compromised during shipment.
- 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
- 26 devices
- Distribution
- Domestic Distribution only to: CA, NY, TX and VA
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K033383"]
- PMA numbers
- not on file
- Product code
- NBC
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28