The Quidel Triage BNP Calibrators
- Company
- Medline Industries Inc
- Recall Initiated
- October 1, 2020
- Terminated
- May 3, 2021
- Recall Number
- Z-0297-2021
- Quantity
- 26 devices
- Firm Location
- Northfield, IL
Reason for Recall
Product compromised during shipment.
Distribution
Domestic Distribution only to: CA, NY, TX and VA
Lot / Code Info
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
Root Cause
Process control
Action Taken
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.