FDA Medical Device Recalls (openFDA)
Medline Industries Inc: RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks to verify correct system measurement.
- Recall number
- Z-1249-2021
- Recalling firm
- Medline Industries Inc
- Product
- RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks to verify correct system measurement.
- Status
- Terminated
- Initiated
- 2021-01-25
- Posted
- not on file
- Terminated
- 2023-01-09
- Reason
- Product was compromised during shipment.
- Root cause
- Process control
- Action
- The firm notified their consignees by letter on 01/25/2021. The letter explained the problem and requested destruction of the product.
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the states of KY, PA, OH.
- Lot, serial or model codes
- lot number 072564
- 510(k) numbers
- ["K853776"]
- PMA numbers
- not on file
- Product code
- JPK
- 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