CLASS II Device recall · Reported 5 May 2021 · FDA Enforcement Report
Trinity Biotech Captia Measles IgM Kit recalled by Clark Laboratories
Clark Laboratories is recalling Trinity Biotech Captia Measles IgM Kit, distributed nationwide in the US. The recall was initiated on 17 Mar 2021 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-1503-2021
- FDA event ID
- 87637
- Recalling firm
- Clark Laboratories, Jamestown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Mar 2021
- FDA classified
- 27 Apr 2021
- Reported
- 5 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Mar 2021 | Recall initiated by company | |
| 27 Apr 2021 | Classified by FDA | +41 days |
| 5 May 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting
Product as listed by the FDA
Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.
Where it was distributed
Worldwide distribution - US Nationwide distribution and the country of Ireland.
Questions about this recall
Is Trinity Biotech Captia Measles IgM Kit recalled?
Yes. Clark Laboratories recalled Trinity Biotech Captia Measles IgM Kit on 17 Mar 2021. The recall is Class II and its status is Terminated. Recall number Z-1503-2021.
Why was it recalled?
Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting
Which lots are affected?
Kit Lot: 2326060-060 Expiration Date: 2021-06-28 (UDI): 05391516743655
Where was it sold?
Worldwide distribution - US Nationwide distribution and the country of Ireland.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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