Mirion Technologies (Capintec), Inc. Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Brand
Mirion Technologies (Capintec), Inc.
Lot Codes / Batch Numbers
Lot Code: Model No: 5430-30151, UDI 859942006096, S/N range 940001 through 941398.
Products Sold
Lot Code: Model No: 5430-30151; UDI 859942006096, S/N range 940001 through 941398.
Mirion Technologies (Capintec), Inc. is recalling Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, due to Complaints of unexpected detachment of the collimator have been reported.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Complaints of unexpected detachment of the collimator have been reported.
Recommended Action
Per FDA guidance
Consignees were sent an URGENT SAFETY NOTICE via email, dated 4/1/24. Consignees are asked to review the provided notice, share the notice with ass affected personnel, instruct personnel to comply with the provided instructions for safe operation and how to perform a retention plate inspection, and to contact Capintec Technical Support if the inspection shows that the collimator is not properly attached. Capintec Technical Support can be reached by phone at 1-800-631-3826 or at 1-201-825-9500, or by email at capintecsupport@mirion.com. Consignees are also asked to confirm receipt of the notification utilizing the provided QR Code or form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026