CLASS III Device recall · Reported 21 Sep 2016 · FDA Enforcement Report
Trinity Biotech Captia Measles IgM recalled
Clark Laboratories, Inc. ( is recalling Trinity Biotech Captia Measles IgM, distributed nationwide in the US. The recall was initiated on 11 Jul 2016 and the FDA has classified it as Class III.
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-2782-2016
- FDA event ID
- 74932
- Recalling firm
- Clark Laboratories, Inc. (, Jamestown, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Jul 2016
- FDA classified
- 12 Sep 2016
- Reported
- 21 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 11 Jul 2016 | Recall initiated by company | |
| 12 Sep 2016 | Classified by FDA | +63 days |
| 21 Sep 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).
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
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
Where it was distributed
Distribution to US nationwide including California, and China (Hong Kong).
Questions about this recall
Is Trinity Biotech Captia Measles IgM recalled?
Yes. Clark Laboratories, Inc. ( recalled Trinity Biotech Captia Measles IgM on 11 Jul 2016. The recall is Class III and its status is Terminated. Recall number Z-2782-2016.
Why was it recalled?
The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).
Which lots are affected?
Lot Number 2326060-043, Expiration Date 31 May 2017
Where was it sold?
Distribution to US nationwide including California, and China (Hong Kong).
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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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