Assayed Bovine Multi-Sera Level 1, Model No. AL1027
This recall has been terminated (originally issued June 10, 2019).
- Recall Initiated
- June 10, 2019
- Terminated
- June 16, 2020
- Recall Number
- Z-2207-2019
- Quantity
- 4 kits (US)
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Domestic distribution to Arizona, Oregon, Washington, and West Virginia. Foreign distribution to Australia, Belarus, Canada, France, Germany, Ireland, Kenya, Korea, Lithuania, New Zealand, Nigeria, Oman, Russia, Singapore, South Africa, Sweden, Switzerland, Turkey, and UK.
Lot / Code Info
205SL
Root Cause
Process design
Action Taken
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.