Recalls / —
—#192689
Product
Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
- FDA product code
- JIN — Nitroprusside, Ketones (Urinary, Non-Quant.)
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- Affected lot / code info
- Model/Item No. S-O2440058; Lots 171793, 169614, 167181, 171713 UDI: 00657498000519
Why it was recalled
Product was improperly store which may cause a delay in results.
Root cause (FDA determination)
Storage
Action the firm took
Consignees were notified via first class mail on March 08, 2022. Consignees are responsible for initiating sub-recalls, where necessary. Medline Industries, LP. has provided each consignee with a letter and a Destruction form to record their response to the recall notification. Each Response received will be recorded and Medline Industries, LP. will send subsequent letters to consignees that have not provided a response to the recall notification in the allotted time. Each consignee was provided with a destruction form to complete and return. The consignees are responsible to destroy their product per their local and state regulations. No product will be returned to Medline.
Recalling firm
- Firm
- MEDLINE INDUSTRIES, LP Northfield
- Address
- 3 Lakes Dr, Northfield, Illinois 60093-2753
Distribution
- Distribution pattern
- US distribution only - AL, CA, FL, GA, IL, IN, LA, MO, MS, NC, NE, NY, OH, PA, VA, and WA
Timeline
- Recall initiated
- 2022-03-08
- Terminated
- 2023-03-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #192689. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.