Recalls / —

—#190677

Product

Premier Rotaclone, Rx only

FDA product code

LIQ — Enzyme Linked Immunoabsorbent Assay, Rotavirus

Device class

Class 1

Medical specialty

Microbiology

510(k) numbers

K852969

Affected lot / code info

Model Number: RID696004, Lot Number 696004N116, Expiration Date 01/12/2023

Why it was recalled

Product stored incorrectly in temperature controlled setting instead of refrigeration.

Root cause (FDA determination)

Process control

Action the firm took

Medline notified consignees on 12/01/2021, via first class mail letter titled URGENT RECALL NOTIFICATION. Customers were instructed to immediately check stock for affected product, quarantine any affected product on hand, complete and return the response form indicating product destroyed, and notify customers if the product was further distributed. An amended customer letter was sent on 12/17/2021. The explanation of the issue was updated. Instructions remained the same.

Recalling firm

Firm

MEDLINE INDUSTRIES, LP Northfield

Address

3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern

US Nationwide distribution in the states of California and Massachusetts.

Timeline

Recall initiated

2021-12-01

Terminated

2023-02-13

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #190677. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.