Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom Assayed Bovine Multi-Sera Level 1, Model No. AL1027 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.

Recommended Action

Per FDA guidance

On June 7, 2019, the firm notified customers of the recall by issuing an Urgent Medical Device Correction letter. Customers were asked to take the following actions: * Inspect your stock and quarantine affected stock on hand to prevent further use. " Discard all value sheets and replace these with the value :sheets provided. " A review of previously generated patient results is not required as control failure is evident at the time of testing. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. *Send a copy of the FSN to all affected customers and to those who need to be aware within your organization. If you have any questions or concerns, please contact Rand ox Technical Services.

Distribution

As reported by FDA

AZ, OR, VA, WA, WV