CLASS II ONGOING Device recall · Reported 5 Jun 2024 · FDA Enforcement Report
Captus 4000e Thyroid Uptake System recalled
Mirion Technologies (Capintec) is recalling Captus 4000e Thyroid Uptake System, distributed nationwide in the US. The recall was initiated on 22 Apr 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1892-2024
- FDA event ID
- 94570
- Recalling firm
- Mirion Technologies (Capintec), Florham Park, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Apr 2024
- FDA classified
- 24 May 2024
- Reported
- 5 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 22 Apr 2024 | Recall initiated by company | |
| 24 May 2024 | Classified by FDA | +32 days |
| 5 Jun 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Complaints of unexpected detachment of the collimator have been reported.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Where it was distributed
Worldwide - US Nationwide distribution and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BANGLADESH, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, FRANCE, GERMANY, GUAM, HONDURAS, HUNGARY, INDIA, ISRAEL, ISREAL, ITALY, JAPAN, KOREA, LATVIA, MALAYSIA, NETHERLANDS, NEW ZEALAND, PAKISTAN, PHILIPPINES, PHILIPPINES , PHILLIPINES, PUERTO RICO, QATAR, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TAIWAN , THAILAND, TURKEY, UNITED KINGDOM, VIETNAM.
Questions about this recall
Why was it recalled?
Complaints of unexpected detachment of the collimator have been reported.
Which lots are affected?
Lot Code: Model No: 5430-30151; UDI 859942006096, S/N range 940001 through 941398.
Where was it sold?
Worldwide - US Nationwide distribution and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BANGLADESH, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, FRANCE, GERMANY, GUAM, HONDURAS, HUNGARY, INDIA, ISRAEL, ISREAL, ITALY, JAPAN, KOREA, LATVIA, MALAYSIA, NETHERLANDS, NEW ZEALAND, PAKISTAN, PHILIPPINES, PHILIPPINES , PHILLIPINES, PUERTO RICO, QATAR, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TAIWAN , THAILAND, TURKEY, UNITED KINGDOM, VIETNAM.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 94570| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Captus 4000e Thyroid Uptake System with Well recalled | Mirion Technologies (Capintec) | Potency & Assay | Nationwide | |
| CLASS II | Captus 4000e Thyroid Uptake System with Well and shielding recalled | Mirion Technologies (Capintec) | Potency & Assay | Nationwide |
More recalls from Mirion Technologies (Capintec)
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Captus 4000e Thyroid Uptake System recalled | Mirion Technologies (Capintec) | Device Malfunction | Nationwide |
| Device | CLASS II | Captus 4000e Thyroid Uptake System with Well and shielding recalled | Mirion Technologies (Capintec) | Potency & Assay | Nationwide |
| Device | CLASS II | Captus 4000e Thyroid Uptake System with Well recalled | Mirion Technologies (Capintec) | Potency & Assay | Nationwide |
| Device | CLASS II | Captus 4000e Thyroid Uptake Systems- Intended to be used recalled | Mirion Technologies (Capintec) | Device Malfunction | Nationwide |
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| Device | CLASS II | McKesson Consult hCG Urine Cassette recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
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| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |